FDA product code BTA: Pump, Portable, Aspiration (Manual Or Powered)
BTA is the FDA product code for pump, portable, aspiration (manual or powered). It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. FDA has cleared 155 510(k) submissions under BTA, 20 in the last five years, from 110 different applicants. The average 510(k) review took 110 days (median 76); 119 days on average over the last three years. FDA has posted 21 recalls for BTA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Portable, Aspiration (Manual Or Powered) |
| Device class | Class II |
| Regulation | 21 CFR 878.4780 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BTA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 54 |
| 2018 | 4 | 149 |
| 2020 | 1 | 122 |
| 2021 | 1 | 197 |
| 2022 | 3 | 62 |
| 2023 | 4 | 234 |
| 2024 | 5 | 128 |
| 2025 | 6 | 102 |
| 2026 | 2 | 127 |
Top BTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medela AG | 9 | 2016-05-18 |
| Thomas Industries | 5 | 2004-06-01 |
| Aeros Instruments, Inc. | 5 | 1995-07-31 |
| Egnell, Inc. | 5 | 1985-11-25 |
| Sscor | 4 | 2004-05-18 |
105 more applicants have BTA clearances. See the full list in Caduvo.
Most recent BTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253107 | Shenzhen Dongjiang Technology Co., Ltd. | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | 2026-04-14 | 202 |
| K260147 | Shenzhen Kingboom Technology Co., Ltd. | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | 2026-03-13 | 52 |
| K251450 | Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | 2025-06-06 | 28 |
| K244033 | Shenzhen Desida Technology Co., Ltd. | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | 2025-05-16 | 137 |
| K251101 | Cro, LLC | AIRO Suction Unit (AIRO-01) | 2025-04-26 | 15 |
Recalls for BTA devices
21 product recalls in 14 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-08-23.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code BTA?
BTA is the FDA product code for pump, portable, aspiration (manual or powered). It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.
What device class is BTA?
Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTA?
Across 155 cleared submissions the average was 110 days from receipt to decision (median 76).
Which companies have the most BTA clearances?
Medela AG (9); Thomas Industries (5); Aeros Instruments, Inc. (5); Egnell, Inc. (5); Sscor (4).
Have BTA devices been recalled?
Yes: 21 product recalls across 14 recall events; the most recent began 2023-08-23.
Next steps
- Run an FDA pathway report with predicate devices for product code BTA
- Run a recall and safety report across every BTA manufacturer
- Watch product code BTA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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