Who is the manufacturer of Stethophone?

Sparrow Acoustics, Inc. filed the 510(k) submission for Stethophone (K231551).

What is the FDA product code for Stethophone?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Stethophone?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Stethophone?

Stethophone v1 (K222871); Eko CORE (K200776).

Who can help prepare an FDA 510(k) submission like Stethophone?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Stethophone

K231551 · Sparrow Acoustics, Inc. · DQD · Oct 12, 2023 · Cardiovascular

Device Facts

Record ID	K231551
Device Name	Stethophone
Applicant	Sparrow Acoustics, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Oct 12, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.

Device Story

Stethophone is a smartphone-based electronic stethoscope application. It utilizes the smartphone's built-in microphone to capture heart and lung sounds. The software provides real-time listening, recording, and cloud storage for later analysis. It features three audio filters (Bell, Diaphragm, Starling) and visualizes sounds via oscillogram and spectrogram. Used by healthcare professionals and lay users in clinical or non-clinical environments; enables remote monitoring and specialist consultation via sound transmission. Healthcare providers use the output to assist in physical examinations and clinical decision-making. Benefits include remote access to auscultation data and improved visualization of chest sounds.

Clinical Evidence

No clinical data. Bench testing only, including repeatability and reproducibility tests, anechoic chamber performance testing, and internal testing by medical analysts and lay users.

Technological Characteristics

Standalone software application operating on iOS smartphones. Uses smartphone microphone for sound acquisition. Frequency response: 20-2000 Hz. Audio filters: Bell (25-300 Hz), Diaphragm (170-850 Hz), Starling (60-1400 Hz). Features digital signal processing (DSP) for amplification and filtering. Visualizations: oscillogram and spectrogram. Cloud-based storage and transmission capabilities.

Indications for Use

Indicated for adult patients for the detection, amplification, filtering, and transmission of heart and lung auscultation sounds. Intended for use by professional or lay users in clinical or nonclinical settings. Not intended for self-diagnosis.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Stethophone v1 (K222871)
Eko CORE (K200776)

Related Devices

K222871 — Stethophone v1 · Sparrow Acoustics, Inc. · Mar 29, 2023
K252595 — Stethophone Pro · Sparrow Acoustics, Inc. · Sep 12, 2025
K240901 — Stethophone · Sparrow Acoustics, Inc. · Sep 19, 2024
K220196 — Steth IO Spot · Stratoscientific · Mar 24, 2022
K160016 — Steth IO · Stratoscientific, Inc. · Jul 15, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 12, 2023 Sparrow Acoustics Inc. Nadia Ivanova Chief Product Officer 2416 Natura Dr Lucasville, NS B4B 0X3 Canada Re: K231551 Trade/Device Name: Stethophone Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: Mav 29, 2023 Received: May 30, 2023 Dear Nadia Ivanova: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Robert T. Kazmierski -S for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Submission Number (if known) K231551 Device Name Stethophone Indications for Use (Describe) Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue, sans-serif font. To the right of the word is a graphic of a bird inside of a circle, with sound waves emanating from the circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, gray, sans-serif font. ## K231551 - 510(k) SUMMARY - 1. Summary Date: May 31, 2023 - 2. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada, B4B 0X3 Tel: +1 (902) 989-3908 - 3. Correspondent: Nadia Ivanova - 4. Device Trade Name: Stethophone - Device Common Smartphone stethoscope ട. Name: - 6. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular - 7. Intended Use/ Stethophone is an electronic stethoscope that enables detection, Indications for Use: amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis. - 8. Device Description: Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users. Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis. Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians. Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in a light blue sans-serif font, with the letter "O" replaced by a stylized image of a bird in a circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font. Kev product features: - · Capturing chest sounds using the smartphone microphone: - Real-time listening to chest sounds, O - Recording of chest sounds, o - · Sending examinations to specialists for assessment - · Two modes of sound visualization: oscillogram and spectrogram, and - · Selection of three audio filters for listening: - Bell: Traditional filter used for low frequency sounds, O - Diaphragm: Traditional filter used for higher frequency o sounds of heart and lungs, and - Starling: Filter for listening to the full frequency of chest O sounds. Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context. | Predicate Devices: | | |------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Stethophone v1 510(k) Number: K222871 Manufacturer: Sparrow Acoustics Inc. Product Code: DQD Classification: 870.1875 | Eko CORE 510(k) Number: K200776 Manufacturer: Eko Devices, Inc. Product Code: DQD Classification: 870.1875 | - 10. Comparison to The comparison chart below provides evidence to facilitate the substantial Predicates: equivalence determination between Stethophone to the predicate devices with respect to intended use, technological characteristics, and principles of operation. | | Stethophone | Stethophone v1 (primary) | Eko CORE | Comments | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | | | | | | Classification | Class II device | Class II device | Class II device | Same | | Regulation | 21 CFR 870.1875(b) | 21 CFR 870.1875(b) | 21 CFR 870.1875(b) | Same | | Product code | DQD | DQD | DQD | Same | | Device | Stethoscope, Electronic | Stethoscope, Electronic | Stethoscope, Electronic | Same | | FDA Clearance | Pending | K222871 | K200776 | | | Intended Use/Indications for Use | | | | | | Intended Use/Indications for Use | Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen | Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be | The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one | Substantially Equivalent | | | | | | | | | sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self- diagnosis. | undergoing physical assessment. | can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self- diagnosis. | | | Prescription/OTS | Prescription and OTC | Prescription | Prescription and OTC | Same | | Population Type | Adults | Adults | Pediatric and adults | Same with Stethophone v1, narrower population than Eko CORE, which doesn't affect safety and performance for the proposed intended use | | Principles of Operation | | | | | | Form Factor | Device that is held in the Doctor's hand is the form of the smartphone | Device that is held in the Doctor's hand is the form of the smartphone | Attachment to an analog stethoscope | Same as Stethophone v1. Different than Eko CORE, which doesn't affect safety and performance | | Dedicated Device vs. iPhone | Operates on iPhone smartphone using its hardware and operating system | Operates on iPhone smartphone using its hardware and operating system | Dedicated proprietary hardware (Attachment to an analog stethoscope) | Same as Stethophone v1. Different than Eko CORE, which doesn't affect safety and performance | | iPhone model Compatibility | 6s, 6S Plus, SE 1st generation, 7, 7 Plus, 8, 8 Plus, X, | 6s, 6S Plus, SE 1st gen, 7, 7 Plus, 8, 8 Plus, X, XS, XS | Any model | Stethophone is available for a larger number | | | XS, XS MAX, XR, SE 2nd generation, 11, 11 Pro, 11 Pro Max, 12, 12 Pro, 12 Mini, 12 Pro Max, 13 mini, 13, 13 Pro, 13 Pro Max, SE 3rd generation, 14, 14 Pro, 14 Pro Max | MAX, XR, SE 2 generation, 11, 11 Pro, 11 Pro Max, 12, 12 Pro, 12 Mini, 12 Pro Max, 13 mini, 13, 13 Pro, 13 Pro Max | | of iPhone models than Stethophone v1, which may affect availability, but doesn't affect safety and performance as stethoscopes | | Software Platform | iOS | iOS | iOS, Android | Same as Stethophone v1. narrower than Eko CORE, which may affect availability, but doesn't affect safety and performance as stethoscopes | | Sound Type | Heart, lungs | Heart, lungs | Heart, lungs, bowel, arteries, and veins | Same as Stethophone v1. narrower than Eko CORE, which may affect availability, but doesn't affect safety and performance for the proposed intended use | | Signal Input Method | Uses microphone of the smartphone to acquire a sound | Uses microphone of the smartphone to acquire a sound | Uses attached analog stethoscope to acquire sound and smartphone to record sound | Same as Stethophone v1. Different than Eko CORE, which doesn't affect safety and performance | | Audio Output Method | Headphones | Headphones | Eartubes of the attached analog stethoscope. Bluetooth headphones paired with Eko App installed on a smartphone can also be used | Same as Stethophone v1, equivalent to Eko CORE | | Record and Playback Sounds | Yes | Yes | Yes | Same | | Real-Time Auscultation | Yes | Yes | Yes | Same | | Filter Selection | Yes | Yes | Yes | Same | | Digital Signal Processing (DSP) | Yes | Yes | Yes | Same | | Display | Smartphone screen | Smartphone screen | Smartphone screen via Eko App | Same | | Sound Visualization | Yes | Yes | Yes | Same | | Technical Characteristics | | | | | | Frequency Response | Stethophone picks up and amplifies the sound between 20 and 2000 Hz. Based on the selected audio filter, specific frequency ranges are further emphasized: Bell filter emphasizes range from 25 to 300 Hz Diaphragm filter emphasizes frequency spectrum range 170-850 Hz, Starling filter works between 60 -1400 Hz. | Stethophone v1 picks up and amplifies the sound between 20 and 2000 Hz. Based on the selected audio filter, specific frequency ranges are further emphasized: Bell filter emphasizes range from 25 to 300 Hz Diaphragm filter emphasizes frequency spectrum range 170-850 Hz, Starling filter works between 60 -1400 Hz. | The default filter is Wide but Cardiac and Pulmonary filters can also be selected to allow the lower and higher frequencies to be emphasized in the sound profile, respectively | Same with Stethophone v1; substantially equivalent to Eko CORE | | Volume Control | Yes | Yes | Yes | Same | | Battery | Uses a built-in battery of a smartphone | Uses a built-in battery of a smartphone | Uses a built-in battery | Same with Stethophone v1; substantially equivalent to Eko CORE | | Recording Lengths | 20 sec | 20 sec | 15-120 sec | Same with Stethophone v1; substantially equivalent to Eko CORE | | Available Sound Visualization | Spectrogram, oscillogram | Spectrogram, oscillogram | Oscillogram | Same with Stethophone v1; substantially equivalent to Eko CORE | | Ability to Zoom | Yes | Yes | Yes | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in large, light blue sans-serif font, with a stylized image of a bird inside a circle replacing the second "R". Below "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font, with the letters spaced out. Stethophone K231551 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the second "R". Below "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters. Stethophone K231551 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside of a circle in the middle of the word. Below the word "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters. Stethophone K231551 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the "O". Below "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters. The logo is clean and modern, with a focus on the company name and a subtle visual element. | 11. | Performance Data: | Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination. | |-----|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving lay users and external medical specialists with auscultation experience. | | 12. | Biocompatibility Testing: | Not Applicable (Standalone Software) | | 13. | Sterilization & Shelf- life Testing: | Not Applicable (Standalone Software). Therefore, it is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation. | | 14. | Electrical safety and electromagnetic compatibility (EMC): | Not Applicable (Standalone Software). Therefore, there is no source of risk for electrical safety or electromagnetic compatibility associated directly with the device. | | 15. | Animal Study: | Animal performance testing was not required to demonstrate safety and effectiveness of the device. | | 16. | Clinical Performance Testing: | Clinical testing was not required to demonstrate the safety and effectiveness of the device. | | 17. | Statement of Substantial Equivalence: | Stethophone and the predicates have the same intended use and similar indications, technological characteristics, and principles of operation. The minor differences do not present different questions of safety or effectiveness than the predicate device. Performance data demonstrates that Stethophone is as safe and effective as the predicate devices. Thus, Stethophone is substantially equivalent to the predicate devices. | This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.