Company · US
3B Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2022. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
3recalls (2 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 2022 | K212263 | Luna G3 BPAP System 3B Medical, Inc. | BZD |
| Jan 29, 2021 | K201620 | Luna® G3 BPAP 25A 3B Medical, Inc. | BZD |
| Jul 24, 2020 | K200496 | Aer X 3B Medical, Inc. | CAW |
| Nov 10, 2016 | K160127 | iCodeConnect 3B Medical, Inc. | BZD |
| Sep 8, 2016 | K153387 | Luna CPAP and Auto CPAP System 3B Medical, Inc. | BZD |
| Apr 22, 2015 | K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM 3B Medical, Inc. | BZD |
| Aug 25, 2014 | K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A 3B Medical, Inc. | BZD |
| Dec 23, 2013 | K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 3B Medical, Inc. | BZD |
| Dec 6, 2013 | K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 3B Medical, Inc. | BZD |
| Aug 22, 2013 | K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS 3B Medical, Inc. | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2026 | 3B Medical, Inc. Brand Name: Rio" II
Product Name: Rio" II Nasal Pillows Interface
Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)
Software Version: N/A
Product Description: Nasal pillows inte Open, Classified |
BZD | K112271 |
| Apr 15, 2026 | 3B Medical, Inc. React Health PHOENIX 5L Oxygen Concentrator Open, Classified |
CAW | K213210 |
| Jan 8, 2025 | 3B Medical, Inc. Brand Name: 3B Medical, Inc.
Product Name: Ultrasoft Oxygen Cannula, 12 Foot
Model / Catalog Number: O2U2012
Lot Number: 20170403
Product Description: Nasal Cannulas for use with Oxygen Concentrators Open, Classified |
BZB | None listed |