# K010263: Remstar Plus Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 29, 2001 after 59 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
141 later devices descend from it; 8 cite it directly.
23 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012554: Remstar Auto Cpap System (2002), 92 descendants of its own
- K031460: Modification to Remstar Auto Cpap System (2003), 74 descendants of its own
- K020777: Bipap Synchrony Ventilatory Support System with BI-Flex (2002), 61 descendants of its own
- K070328: Bipap Synchrony with Avaps (2007), 59 descendants of its own
- K021861: Remstar Pro with C-Flex Cpap System (2002), 47 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1066-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 25, 2006 · Not classified · Z-0447-2007: AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
- Oct 25, 2006 · Not classified · Z-0446-2007: AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device

Source page: https://510kreport.com/device/K010263
Methodology: https://510kreport.com/methodology