Electric nasal aspirator (HTD2601US)
FDA 510(k) K241202 · Hetaida Technology Co., Ltd.
510(k) numberK241202
Submission
- Device name
- Electric nasal aspirator (HTD2601US)
- Applicant
- Hetaida Technology Co., Ltd.
Dongguan City, CN - Received
- April 30, 2024
- Decision date
- July 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243661 | Electronic Blood Pressure MonitorDXN · Special | 02/07/2025SE |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602USDXN · Traditional | 12/05/2023SE |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CFLL · Special | 02/25/2021SE |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823USFLL · Traditional | 01/05/2021SE |
| K180387 | Infrared Ear ThermometerFLL · Traditional | 01/10/2019SE |
| K171888 | Non-contact infrared body thermometerFLL · Traditional | 07/23/2018SE |
| K180385 | Infrared Body ThermometerFLL · Traditional | 05/11/2018SE |
Questions and answers
When was Electric nasal aspirator (HTD2601US) cleared by the FDA?
Electric nasal aspirator (HTD2601US) (K241202) received a 510(k) decision of Substantially Equivalent on July 1, 2024, 62 days after the submission was received.
What is the product code of K241202?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.