# K131707: 3B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems

- Pathway: 510(k) (Special)
- Applicant: 3B Medical, Inc.
- Decided: Aug 22, 2013 after 72 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953930 (1996). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110629: Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier, 3B Products, Inc. (2012) Summary page 1.

## Most influential descendants
- K133769: 3B Resmart Bpap 25A, BMC Resmart Bpap 25A (2014), 3 descendants of its own
- K201620: Luna® G3 BPAP 25A (2021), 2 descendants of its own
- K213169: BPAP System (2022), 0 descendants of its own
- K212263: Luna G3 BPAP System (2022), 0 descendants of its own

## Indications for use
The 3B and BMVC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended far single patient use by prescription in the home or hospital/intuitional environment on adult patients.

Source page: https://510kreport.com/device/K131707
Methodology: https://510kreport.com/methodology