Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3B Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
248 daysmedian FDA review time
295 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022-03-25 | 248 | 0 |
| K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021-01-29 | 228 | 0 |
| K200496 | Aer X | 3B Medical, Inc. | 2020-07-24 | 147 | 0 |
| K160127 | iCodeConnect | 3B Medical, Inc. | 2016-11-10 | 295 | 0 |
| K153387 | Luna CPAP and Auto CPAP System | 3B Medical, Inc. | 2016-09-08 | 290 | 0 |
| K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM | 3B Medical, Inc. | 2015-04-22 | 295 | 0 |
| K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | 3B Medical, Inc. | 2014-08-25 | 257 | 0 |
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | 3B Medical, Inc. | 2013-12-23 | 181 | 0 |
| K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPA | 3B Medical, Inc. | 2013-12-06 | 77 | 0 |
| K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND | 3B Medical, Inc. | 2013-08-22 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda