# K131502: Seattle - Pap

- Pathway: 510(k) (Traditional)
- Applicant: Seattle Childrens Hospital
- Decided: Oct 11, 2013 after 140 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 5 devices in its family (counting itself) has 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 2.

## Recalls of this device
- Apr 17, 2023 · Class I · Z-1439-2023: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

## Indications for use
The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician. It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Source page: https://510kreport.com/device/K131502
Methodology: https://510kreport.com/methodology