Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875) → LDE — Stethoscope, Manual # LDE · Stethoscope, Manual _Cardiovascular · 21 CFR 870.1875 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE ## Overview - **Product Code:** LDE - **Device Name:** Stethoscope, Manual - **Regulation:** [21 CFR 870.1875](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1875) - **Device Class:** 1 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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. ## Classification Rationale Manual stethoscope: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. Electronic stethoscope: 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. ## 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. ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K945082](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K945082.md) | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | Cypress Medical Products, Ltd. | Dec 8, 1994 | SESE | | [K944337](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K944337.md) | VARIOUS STETHOSCOPES | Rud Riester GmbH & CO KG | Nov 30, 1994 | SESE | | [K940578](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K940578.md) | MANUAL STETOSCOPE | Bhs Intl., Inc. | Apr 26, 1994 | SESE | | [K935944](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K935944.md) | PROSCOPES AND ADSCOPES | American Diagnostic Corp. | Mar 3, 1994 | SESE | | [K923327](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K923327.md) | STETHOSCOPE COVER | Anup Chakraborty Co. | Nov 3, 1992 | SESE | | [K924095](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K924095.md) | TIMEOSCOPE AND FLEXISCOPE | Stethoscopes of America, Inc. | Oct 20, 1992 | SESE | | [K914100](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K914100.md) | STETHOSCOPE | Atlas Medical Products, Inc. | Nov 7, 1991 | SESE | | [K912128](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K912128.md) | MAXI-SCOPE OR ULTRA-SCOPE | Seiichi Mfg., Inc. | Jun 28, 1991 | SESE | | [K905487](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K905487.md) | VARIOUS TYPES OF STETHOSCOPES | Liaoning-Usa Corp. | Apr 9, 1991 | SESE | | [K904547](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K904547.md) | STETHOSCOPE | Kimball Industries Co., Ltd. | Mar 21, 1991 | SESE | | [K895545](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K895545.md) | V*S*R(TM) SCOPE | Vsr Enterprises Corp. | Nov 15, 1989 | SESE | | [K890126](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K890126.md) | KAMED STETHOSCOPE | D.R.G. | Apr 21, 1989 | SESE | | [K882324](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K882324.md) | STETH-SHIELD ACCESSORY TO A STETHOSCOPE | Steth-Shield, Inc. | Jul 18, 1988 | SESE | | [K871369](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K871369.md) | VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: | Keeler Instruments, Inc. | Sep 24, 1987 | SESE | | [K860473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K860473.md) | DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE | Schering Corp. | Aug 14, 1986 | SESE | | [K854771](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K854771.md) | SALTZMAN STETHOSCOPE HEAD | K & S Medicorp | May 9, 1986 | SESE | | [K843324](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K843324.md) | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Cher Mel Corp. | Jun 6, 1985 | SESE | | [K842203](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K842203.md) | LITTMAN TYPE SH-6010, NURSE TYPE | Cher Mel Corp. | Jun 6, 1985 | SESE | | [K830796](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K830796.md) | THE BLOOM STETHOSCOPE | Stethophonics, Inc. | Jul 19, 1983 | SESE | | [K821909](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE/K821909.md) | LITTMAN TUNABLE STETHOSCOPE 2136 | 3M Company | Jul 14, 1982 | SESE | ## Top Applicants - Conphar, Inc. — 3 clearances - Cher Mel Corp. — 2 clearances - 3M Company — 1 clearance - Abco Dealers, Inc. — 1 clearance - American Diagnostic Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LDE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com