# K221436: F&P 950 Accessory Breathing Circuit Kits

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jun 29, 2023 after 408 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: 3 generations back to K902859 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100011: Fisher & Paykel Healthcare Bubble Cpap System, Fisher & Paykel Healthcare, Ltd. (2010) Summary page 4.

## Indications for use
950N60J – Bubble CPAP Dual Heated Circuit Kit The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications. 950N62J – Bubble CPAP Dual Heated Circuit Kit (for Hudson interface) The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.

Source page: https://510kreport.com/device/K221436
Methodology: https://510kreport.com/methodology