R&D Batteries, Part Nos. 5243, 5104, and 5481
FDA 510(k) K942033 · R & D Batteries, Inc.
510(k) numberK942033
Submission
- Device name
- R&D Batteries, Part Nos. 5243, 5104, and 5481
- Applicant
- R & D Batteries, Inc.
Burnsville, MN, US - Received
- April 28, 1994
- Decision date
- June 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | 12/08/2014SE |
| K951404 | R&D Batteries Part Nos. 5096, 5115, 5128 and 5131FLL · Traditional | 08/18/1995SE |
| K951403 | R&D Batteries Part Nos. 5164, 5252, 5634 and 5650FLL · Traditional | 08/18/1995SE |
| K951402 | R&D Batteries Part Nos. 5167, 5221, 5244 and 5247FLL · Traditional | 08/18/1995SE |
| K951401 | R&D Batteries Part Nos. 5015, 5016, 5037 and 5051FLL · Traditional | 08/18/1995SE |
| K951400 | R&D Batteries Part Nos. 5064, 5157, 5489 and 5536FLL · Traditional | 08/18/1995SE |
| K951399 | R&D Batteries Part Nos. 5041 & 5655FLL · Traditional | 08/18/1995SE |
| K951285 | R&D Batteries, Inc. Part Numbers 5158, 5168, 5171 and 5172FLL · Traditional | 08/18/1995SE |
| K951284 | R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155FLL · Traditional | 08/18/1995SE |
| K951283 | R&D Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123FLL · Traditional | 08/18/1995SE |
Questions and answers
When was R&D Batteries, Part Nos. 5243, 5104, and 5481 cleared by the FDA?
R&D Batteries, Part Nos. 5243, 5104, and 5481 (K942033) received a 510(k) decision of Substantially Equivalent on June 28, 1994, 61 days after the submission was received.
What is the product code of K942033?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.