510(k) K150134
- Device
- Basic, Dominant Flex, KV-6
- Applicant
- MEDELA AG
- 510(k) number
- K150134
- Product code
- BTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-21
- Date received
- 2015-01-21
- Regulation
- 878.4780
- Classification name
- Pump, Portable, Aspiration (manual Or Powered)
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ORLANDO ANTUNES
- Address
- Lattichstrasse 4b Baar CH 6341 6341
FDA Registration Numbers#
- 1058584
- 3004112621
- 3011423170
- 3030230686
- 1220246
- 2523676
- 1047843
- 3007279404
- 3007829657
- 1045254
- 3002807523
- 3011163668
- 1222928
- 3009039068
- 2032809
- 2030580
- 2435119
- 2028523
- 3008837339
- 3009103001
- 3007593903
- 3006611221
- 3022320321
- 3038715747
- 3038613815
- 3008717566
- 3022978896
- 1645337
- 1000655158
- 3003587189
- 3009420598
- 3018094310
- 3003755939
- 3005670221
- 2030624
- 3014903258
- 2022994
- 3010400367
- 2032098
- 1313525
- 1118193
- 3006142527
- 2020601
- 2027804
- 3007697975
- 3004878380
- 3011533696
Source Documents#
Other 510(k) Records For Product Code BTA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 |
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. | 2025-06-06 |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025-04-26 |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG | 2025-03-07 |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025-02-04 |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024-12-31 |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | 2024-07-01 |
Legacy Summary#
summary
FDA Review#
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