# K131982: Remstar Auto a-Flex HT

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Oct 18, 2013 after 112 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K953930 (1996). 31 ancestors in all.
5 later devices descend from it; 2 cite it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113068: Remstar Auto a-Flex HT, Respironics, Inc. (2011) Summary page 1.

## Most influential descendants
- K201620: Luna® G3 BPAP 25A (2021), 2 descendants of its own
- K200480: DreamStation 2 System, DreamStation 2 Advanced System (2020), 1 descendant of its own
- K251770: SleepRes PAP System (2025), 0 descendants of its own
- K213169: BPAP System (2022), 0 descendants of its own
- K212263: Luna G3 BPAP System (2022), 0 descendants of its own

## Recalls of this device
- Jun 30, 2025 · Class I · Z-2227-2025: Devices may possess a programming error resulting in an incorrect device configuration.
- Jun 30, 2025 · Class I · Z-2229-2025: Devices may possess a programming error resulting in an incorrect device configuration.
- Jun 30, 2025 · Class I · Z-2228-2025: Devices may possess a programming error resulting in an incorrect device configuration.
- Feb 10, 2023 · Class I · Z-1322-2023: A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect t
- 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 i-T 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/K131982
Methodology: https://510kreport.com/methodology