# K113068: Remstar Auto a-Flex HT

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Dec 16, 2011 after 60 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K953930 (1996). 30 ancestors in all.
9 later devices descend from it; 3 cite it directly.
5 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091319: Remstar Auto a-Flex, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 1.

## Most influential descendants
- K131982: Remstar Auto a-Flex HT (2013), 5 descendants of its own
- K122769: Remstar SE (2012), 3 descendants of its own
- K201620: Luna® G3 BPAP 25A (2021), 2 descendants of its own
- K130077: Remstar SE (2013), 2 descendants of its own
- K200480: DreamStation 2 System, DreamStation 2 Advanced System (2020), 1 descendant of its own

## Recalls of this device
- Apr 1, 2024 · Class I · Z-1817-2024: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insuffi
- 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 Auto A-Flex HT 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/K113068
Methodology: https://510kreport.com/methodology