Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
Device Facts
| Record ID | K260473 |
|---|---|
| Device Name | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) |
| Applicant | Shenzhen Kingboom Technology Co., Ltd. |
| Product Code | BTA · General, Plastic Surgery |
| Decision Date | May 12, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Device Story
Portable electric nasal aspirator; models BC027, BC030, BC033, BC035, BC035B. Device consists of main unit and suction chamber; motor pump generates negative pressure to remove nasal secretions. Microprocessor controls vacuum pressure; user interface includes keypad and LED display. Powered by rechargeable Li-ion battery (BC027, BC030, BC033) or AA alkaline batteries/mains (BC035, BC035B). Used in home environment by caregivers to assist children. Some models include music and light functions to distract/pacify child. Output is physical removal of mucus; healthcare provider/caregiver observes output to assess clearance. Benefits include improved nasal breathing for child.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including product service life, software validation, electromagnetic compatibility, electrical safety, and functional performance testing.
Technological Characteristics
Powered suction pump; materials include ABS, PC, and silicone. Type BF applied part. IP22 water resistance. Vacuum range 60-75 kPa; flow rates 2.8-9.0 L/min. Powered by 3.7V Li-ion battery or 4AA alkaline batteries. Microprocessor-controlled vacuum. Sterilization/cleaning: reusable silicone tips. Standards: ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1, IEC 62133-2, IEC 62471, IEC 62304.
Indications for Use
Indicated for intermittent removal of nasal secretions and mucus in children aged 2-12 years old in a home environment.
Regulatory Classification
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Predicate Devices
- Electric nasal aspirator, model: HTD2601US, H2609AU (K241202)
Reference Devices
- Electric nasal aspirator, model: BC026 (K222547)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 12, 2026
Shenzhen Kingboom Technology Co., Ltd.
% Reanny Wang
General Manager
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Room 1509, Jingting Building, Dongzhou Community
Guangming Street, Guangming District
Shenzhen, Guangdong 518107
China
Re: K260473
Trade/Device Name: Electrical Nasal Aspirator
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump
Regulatory Class: Class II
Product Code: BTA
Dated: February 10, 2026
Received: February 12, 2026
Dear Reanny Wang:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260473 - Reanny Wang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K260473 - Reanny Wang
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assistance/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,
JOYCE C. LIN -S
for Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260473 | ? |
| Please provide the device trade name(s). | | ? |
| Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | | |
| Please provide your Indications for Use below. | | ? |
| The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) | ? |
| | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) | ? |
| | ☐ Infants (29 days old to < 2 years old) | |
| | ☑ Children (2 years old to < 12 years old) | |
| | ☐ Adolescents (12 years old to < 22 years old) | |
| | ☐ Adults (22 years old and greater) | |
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510(k) Summary – K260473
1. Information of Submitter and Correspondent
Submitter’s information:
Company Name: Shenzhen Kingboom Technology Co., Ltd
Street Address: #201, 2nd floor, No.5, Tongxin Road, Pingdong Community, Pingdi Street, Longgang District
City: Shenzhen
State/Province: Guangdong
Country: China
Telephone: +86-13590244726
Fax: /
Contact Person: Ma Qiang
Contact Title: General Manager
Contact Email: 156673750@qq.com
Date Prepared: May 8, 2026
Submission correspondent’s information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1509, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
Phone: +86(755) 27391220
2. Device Information
Trade Name: Electric nasal aspirator
Model: BC027, BC30, BC033, BC035 and BC035B
Common Name: Powered suction pump
Classification Name: Pump, portable, aspiration (powered)
Regulation: 21 CFR § 878.4780
Device Class: Class 2
Product Code: BTA
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3. Identification of Predicate Device(s)
| Predicate | Predicate Device | Reference Device |
| --- | --- | --- |
| Manufacturer | Hetaida Technology Co., Ltd. | Shenzhen XinLianFeng Technology CO.,LTD |
| Legally Marketed Device | Electric nasal aspirator, model: HTD2601US, H2609AU | Electric nasal aspirator, model: BC026 |
| 510(K) Number | K241202 | K222547 |
| Product code | BTA | BTA |
| Device class | Class II | Class II |
4. Description of Device
Electric nasal aspirator is consist of a separate main unit, suction chamber. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The microprocessor provides control over vacuum pressure. The motor unit operates on a rechargeable battery (BC027, BC030, BC033), dry alkaline batteries and mains powered (BC035, BC035B). The rechargeable battery (BC027, BC030, BC033) can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of a panel keypad and LED display (BC027, BC030, BC033), and the user can control the vacuum pressure through the button.
The differences between BC027, BC030, BC033, BC035, BC035B are as follows:
| Different items | BC027 | BC030 | BC033 | BC035 | BC035B |
| --- | --- | --- | --- | --- | --- |
| Vacuum range | ≤68kPa | ≤68kPa | ≤68kPa | 60 to 75 kPa | 60 to 75 kPa |
| Flow level | 5 levels; Level1: 2.8-3.7L/min; level 2: 3.8-4.7L/min; level 3: 4.8-5.7L/min level 4: 5.8-6.7L/min level 5: 6.8-9.0L/min | 5 levels; Level1: 2.8-3.7L/min; level 2: 3.8-4.7L/min; level 3: 4.8-5.7L/min level 4: 5.8-6.7L/min level 5: 6.8-9.0L/min | 5 levels; Level1: 2.8-3.7L/min; level 2: 3.8-4.7L/min; level 3: 4.8-5.7L/min level 4: 5.8-6.7L/min level 5: 6.8-9.0L/min | 3 levels; Level1: 2.8-4.3L/min; level 2: 4.4-6.4L/min; level 3: 6.5-9.0L/min | 3 levels; Level1: 2.8-4.3L/min; level 2: 4.4-6.4L/min; level 3: 6.5-9.0L/min |
| Charging Input | DC 5V 2.0A(Charge through provided USB 2.0/Type-C charging line and self purchased power adapter) | DC 5V 2.0A(Charge through provided USB 2.0/Type-C charging line and self purchased power adapter) | DC 5V 2.0A(Charge through provided USB 2.0/Type-C charging line and self purchased power adapter) | N/A | N/A |
| Power supply | DC 3.7 V / 2500mAh Rechargeable Li-ion battery | DC 3.7 V / 2500mAh Rechargeable Li-ion battery | DC 3.7 V / 2500mAh Rechargeable Li-ion battery | DC 5V 2.0A (Optional Power Supply Methods: Charge through provided USB 2.0/Type-C USB line and power adapter) or self purchased 4AA dry | DC 5V 2.0A (Charge through provided USB 2.0/Type-C USB line and power adapter) or self purchased 4AA dry alkaline batteries (LR6 1.5V) |
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| | | | | alkaline batteries (LR6 1.5V) | |
| --- | --- | --- | --- | --- | --- |
| Tips Dimension (φ) | Gourd Nozzle: OD6/ID4.8 Pointed-nosed nozzle: OD4/ID2.3 | Gourd Nozzle: OD6/ID4.8 Pointed-nosed nozzle: OD4/ID2.3 | Gourd Nozzle: OD6/ID4.8 Pointed-nosed nozzle: OD4/ID2.3 | Big funnel suction nozzle: OD5/ID3.2 Small funnel suction nozzle: OD4/ID2.3 | suction nozzle: OD6.2/ID3 |
| Light (used for distract and pacify the child) | yes | yes | yes | no | no |
| Pause suction function | yes | yes | yes | no | no |
| Button | Power button Flow level button Music button Light button | Power button Music button Flow level button Light button | Power button Flow rate & Volume Button Music button Light button | Power button | Power button |
| Display | LED digital display | LED digital display | LED digital display | LED beads display | LED beads display |
| Size: | 130MM*90MM*50MM | 116MM*96MM*50MM | 102MM*94MM*51MM | 114MM*95MM*52MM | 114MM*95MM*52MM |
| weight | 440±10g | 463±10g | 455±10g | 283±5g | 283±5g |
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5. **Indications for Use**
The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
6. **Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:**
6.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
6.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
7. **Performance Summary**
The devices conform to applicable standards as follow table:
| Test Type | Standard Designation Number | Outcome for Device |
| --- | --- | --- |
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Conforms |
| EMC | IEC 60601-1-2:2020 IEC TR 60601-4-2: 2016 | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Conforms |
| Biocompatibility | ISO 10993-1:2018 | Conforms |
| Software | ANSI AAMI IEC 62304:2006/A1:2016 | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017/A1:2021 | Conforms |
| Safety of lamps | IEC 62471: 2006 | Conforms |
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Biocompatibility: The patient contact part (Suction Nozzle) utilized in the subject device is the same as the FDA cleared BC026 Electric nasal aspirator in K222547, their relationship to the patient for the subject device are identical in formation, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
# 8. Discussion of Comparison to Predicate Devices.
The Electric nasal aspirator submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics, materials, and performance to the cleared Electric nasal aspirator K241202 and K222547. Differences between the subject and predicate device and reference device do not raise new questions of safety and effectiveness.
| Device | Subject device | Predicate device | Reference Device |
| --- | --- | --- | --- |
| Manufacturer | Shenzhen Kingboom Technology Co., Ltd | Hetaida Technology Co., Ltd. | Shenzhen XinLianFeng Technology Co., LTD |
| 510(K) number | K260473 | K241202 | K222547 |
| Product name | Electric nasal aspirator | Electric nasal aspirator | Electric nasal aspirator |
| Model | BC027, BC030, BC033, BC035, BC035B | HTD2601US, H2609AU | BC026 |
| Classification | Class II Device, BTA (21 CFR § 878.4780) | Class II Device, BTA (21 CFR § 878.4780) | Class II Device, BTA (21 CFR § 878.4780) |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use |
| Indication for Use | The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment. | The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment. | The Electric nasal aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment. |
| Patient Population | Age 2-12 years old | Age 2-12 years old | Age 2-12 years old |
| Intended Environment | Home use | Home use | Home use |
| Device Description | The BC027, BC030, BC033, BC035, BC035B Electric nasal aspirator is a device which is intended for suction of nasal passages in children 2-12 years of age. The device is designed with a separate main unit and suction chamber. The motor pump provides a negative pressure which removes nasal secretions. | The HTD2601US and H2609AU Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. | The BC026 Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. |
| Vacuum pressure | BC027, BC030, BC033: ≤ 68kPa BC035, BC035B: 60 to 75 kPa | ≤68kPa | 52-60Kpa |
| Maximum flow value | BC027, BC030, BC033: Level1: 2.8-3.7L/min; level 2: 3.8-4.7L/min; level 3: 4.8-5.7L/min level 4: 5.8-6.7L/min level 5: 6.8-9.0L/min | ≥1.6L/min | Not disclosed |
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| Device | Subject device | Predicate device | Reference Device |
| --- | --- | --- | --- |
| | BC035, BC035B: Level1: 2.8-4.3L/min; level 2: 4.4-6.4L/min; level 3: 6.5-9.0L/min | | |
| Music and Light function | BC027, BC030, BC033 : Yes BC035, BC035B: No | No | Yes |
| Noise Level | <80dBA | ≤60dB | <80dBA |
| Power consumption | 3.75W | 1.5W | 2.2W |
| Motor Type | 5.0V DC | 3.7V DC | 3.7V DC |
| Power Source | BC027, BC030, BC033: DC 3.7 V / 2500mAh Rechargeable Li-ion battery BC035, BC035B: self purchased 4AA dry alkaline batteries (LR6 1.5V) or DC 5V 2.0A (Charge through provided USB 2.0/Type-C USB line and power adapter) | DC 3.7 V / 500mAh Rechargeable Li-ion battery | DC 3.7 V / 700mAh Rechargeable Li-ion battery |
| Device Dimension | BC027: 130MM*90MM*50MM BC030: 116MM*96MM*50MM BC033: 102MM*94MM*51MM BC035, BC035B: 114MM*95MM*52MM | HTD2601US: 185 mm x 42 mm x 42 mm (Lx WxH) H2609AU: 191 mm x 42 mm x 42 mm (Lx WxH) | 160 (H) x 41 (L) x 41 (W)mm |
| Weight | BC027: 440±10g BC030: 463±10g BC033: 455±10g BC035, BC035B: 283±5g | Approx.167g | 320±5g |
| Tips Dimension (ψ) | BC027, BC030, BC033: Gourd Nozzle: OD6/ID4.8 Pointed-nosed nozzle : OD4/ID2.3 BC035: Big funnel suction nozzle: OD5/ID3.2 Small funnel suction nozzle: OD4/ID2.3 BC035B: suction nozzle: OD6.2/ID3 | Type1: OD4.1mm/ID2.3mm Type2: OD7.9mm/ID3.0mm | OD4.3/ID2.4 |
| Main Materials | ABS, PC, Silicone | ABS, PCTG, Silicone | ABS, PC, Silicone |
| Operating condition | 5°C (41°F) to 40°C (104°F); 15% to 93% R.H. | 5°C (41°F) to 40°C (104°F); ≤85% R.H. | 5°C (41°F) to 40°C (104°F); 15% to 93% R.H. |
| Storage condition | -10°C(-23°F) to 70°C (158°F); 10% to 95% R.H. | -20°C(-4°F) to 55°C (131°F); ≤93% R.H. | -10°C(-23°F) to 70°C (158°F); 10% to 95% R.H. |
| Expected service life | 2 years | 5 years | 2 years |
| Type BF applied part | Type BF applied part | Type BF applied part | Type BF applied part |
| Safety | IEC 60601-1 IEC 60601-1-11 | ANSI AAMI ES60601-1 ANSI AAMI HA60601-1- | IEC 60601-1 IEC 60601-1-11 |
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| Device | Subject device | Predicate device | Reference Device |
| --- | --- | --- | --- |
| | IEC 62133-2 IEC 62471 | 11 IEC 62133-2 | IEC 62133-2 IEC 62471 |
| EMC | IEC 60601-1-2 | ANSI AAMI IEC 60601-1-2 | IEC 60601-1-2 |
| Water-resistance | IP22 | IP22 | IP22 |
| Biocompatibility | BC027, BC030, BC033, BC035, BC035B operates in conjunction with silicone nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. | HTD2601US and H2609AU operates in conjunction with silicone nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. | BC026 operates in conjunction with silicone nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. |
| Standard of Biocompatibility | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 |
| Contacted Parts | Silicone Tip (funnel nozzle) | Silicone Tip (funnel nozzle) | Silicone Tip (funnel nozzle) |
| Material of contacted parts | Silicone | Silicone | Silicone |
## 9. Conclusions
Based on performance testing, comparison and analysis, the subject device Electric nasal aspirator (model: BC027, BC030, BC033, BC035, BC035B) is substantially equivalent to the predicate device and reference device.
