3B Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “3B Medical, Inc.” (first 2013, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 238 days. Since 2017 the median was 228 days, against 220 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 3 | 77 |
| 2014 | 1 | 257 |
| 2015 | 1 | 295 |
| 2016 | 2 | 292 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 147 |
| 2021 | 1 | 228 |
| 2022 | 1 | 248 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 3B Medical, Inc. took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 9 | 9 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
Review panels
- Anesthesiology (10)
Most recent 3B Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212263 | Luna G3 BPAP System | BZD | 2022-03-25 | 248 |
| K201620 | Luna® G3 BPAP 25A | BZD | 2021-01-29 | 228 |
| K200496 | Aer X | CAW | 2020-07-24 | 147 |
| K160127 | iCodeConnect | BZD | 2016-11-10 | 295 |
| K153387 | Luna CPAP and Auto CPAP System | BZD | 2016-09-08 | 290 |
| K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM | BZD | 2015-04-22 | 295 |
| K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | BZD | 2014-08-25 | 257 |
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | BZD | 2013-12-23 | 181 |
| K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | BZD | 2013-12-06 | 77 |
| K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS | BZD | 2013-08-22 | 72 |
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2026-02-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under 3B Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “3B Medical, Inc.” (first 2013, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 3B Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3B Medical, Inc. is 238 days. Since 2017: 228 days, versus 220 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 3B Medical, Inc.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 9); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 10 3B Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZD, 3B Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.