Fraser Harlake Emerg. Care Suction Sys
FDA 510(k) K841903 · Fraser Harlake, Inc.
510(k) numberK841903
Submission
- Device name
- Fraser Harlake Emerg. Care Suction Sys
- Applicant
- Fraser Harlake, Inc.
Walker, MI, US - Received
- May 7, 1984
- Decision date
- June 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K833799 | Sphygomano MeterDXN · Traditional | 05/14/1984SE |
| K841496 | Fraser Harlake Hope III ResuscitatorBTM · Traditional | 04/24/1984SE |
| K833692 | Fraser Harlake Dental Anti-Polution SysCBN · Traditional | 11/29/1983SE |
| K833151 | Boyle System Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
| K831427 | Cyprane Tec 4 Continuous Flow Vapor.CAD · Traditional | 07/07/1983SE |
| K822040 | Powered Emergency VentilatorCBK · Traditional | 08/19/1982SE |
| K821744 | Fraser Harlake Nitronox ScavengerCBN · Traditional | 06/25/1982SE |
| K802943 | Positive End Expiratory Pressure ValveBYE · Traditional | 01/15/1981SE |
Questions and answers
When was Fraser Harlake Emerg. Care Suction Sys cleared by the FDA?
Fraser Harlake Emerg. Care Suction Sys (K841903) received a 510(k) decision of Substantially Equivalent on June 14, 1984, 38 days after the submission was received.
What is the product code of K841903?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.