# K100011: Fisher & Paykel Healthcare Bubble Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Oct 8, 2010 after 277 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902859 (1991). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 1.

## Most influential descendants
- K221436: F&P 950 Accessory Breathing Circuit Kits (2023), 0 descendants of its own
- K143700: CPAP Cannulaide (2015), 0 descendants of its own
- K131502: Seattle - Pap (2013), 0 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician. The Bubble CPAP System is for use in the hospital clinical environment such as the NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit). The intended patient population is premature and full term neonates up to a weight of 10 kg. All components of the Bubble CPAP System are single use only.

Source page: https://510kreport.com/device/K100011
Methodology: https://510kreport.com/methodology