# K072996: Remstar Pro M-Series Cpap & Heated Humidifier System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Dec 27, 2007 after 64 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953930 (1996). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052110: M-Series Pro Cpap Sytem, Respironics, Inc. (2005) Summary page 1.

## Most influential descendants
- K120285: K Series Cpap System with Heated Humidifer (2012), 3 descendants of its own
- K123897: K Series Cpap Systems (2013), 2 descendants of its own
- K130828: K Series Cpap Systems (2014), 0 descendants of its own
- K131702: K Series Cpap Systems (2013), 0 descendants of its own

## Recalls of this device
- Feb 5, 2009 · Not classified · Z-1260-2009: Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the 

## Indications for use
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K072996
Methodology: https://510kreport.com/methodology