# K130077: Remstar SE

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: May 21, 2013 after 127 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K953930 (1996). 33 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122769: Remstar SE, Respironics, Inc. (2012) Summary page 1.

## Most influential descendants
- K200480: DreamStation 2 System, DreamStation 2 Advanced System (2020), 1 descendant of its own
- K251770: SleepRes PAP System (2025), 0 descendants of its own

## Recalls of this device
- Jun 14, 2021 · Class I · Z-1974-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain c

## Indications for use
The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 Ibs). It is for use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K130077
Methodology: https://510kreport.com/methodology