# K110629: Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: 3B Products, Inc.
- Decided: Apr 27, 2012 after 420 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: 3 generations back to K953930 (1996). 10 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012554: Remstar Auto Cpap System, Respironics, Inc. (2002) Summary page 7.
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink, Resmed, Ltd. (2003) Summary page 7.

## Most influential descendants
- K132967: 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap (2013), 4 descendants of its own
- K131707: 3B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems (2013), 4 descendants of its own
- K141770: Luna Cpap and Auto-Cpap System (2015), 3 descendants of its own
- 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

## Indications for use
The 3B and BMC 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 for single patient use by prescription in the home or hospital/institutional environment on adult patients.

Source page: https://510kreport.com/device/K110629
Methodology: https://510kreport.com/methodology