# 3B Medical, Inc.

- Location (FDA's records): Lake Wales, FL
- FDA decisions: 10 (2013–2022): 10 510(k) clearances
- Product codes: BZD (9), CAW (1)
- 510(k) review time since 2016: median 248 days, against 217 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 14 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 3 (https://510kreport.com/company/resmed)
- 3B Products, LLC: 3 (https://510kreport.com/company/3b-products)
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Vbox, Inc.: 1 (https://510kreport.com/company/vbox)

## Firms that cite its devices most
- BMC Medical Co., Ltd.: 2 (https://510kreport.com/company/bmc-medical)
- Resvent Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/resvent-medical-technology)

## Its most-cited devices
- K153387: Luna CPAP and Auto CPAP System (2016), cited by 2
- K201620: Luna® G3 BPAP 25A (2021), cited by 2
- K131707: 3B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems (2013), cited by 1
- K132967: 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap (2013), cited by 1
- K141770: Luna Cpap and Auto-Cpap System (2015), cited by 1
- K133769: 3B Resmart Bpap 25A, BMC Resmart Bpap 25A (2014), cited by 1

## Recent decisions
- K212263: Luna G3 BPAP System (Mar 25, 2022)
- K201620: Luna® G3 BPAP 25A (Jan 29, 2021)
- K200496: Aer X (Jul 24, 2020)
- K160127: iCodeConnect (Nov 10, 2016)
- K153387: Luna CPAP and Auto CPAP System (Sep 8, 2016)
- K141770: Luna Cpap and Auto-Cpap System (Apr 22, 2015)
- K133769: 3B Resmart Bpap 25A, BMC Resmart Bpap 25A (Aug 25, 2014)
- K131901: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 (Dec 23, 2013)

Source page: https://510kreport.com/company/3b-medical