# K040366: Pressure Manifold, Model BC 110

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Mar 4, 2004 after 20 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831246 (1983). 1 ancestor in all.
23 later devices descend from it; 3 cite it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831246: Whistler in-Line Pressure Release Valve, Airlife, Inc. (1983) Summary page 1.

## Most influential descendants
- K072703: Pioneer Slimfuse Anterior Cervical Plating System (2008), 19 descendants of its own
- K100708: Pioneer Anterior Cervical Plate Model 24-Series (2010), 12 descendants of its own
- K111528: Pioneer Aspect Anterior Cervical Plate Model 24-Series (2011), 11 descendants of its own
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own
- K130427: Pioneer Aspect Anterior Cervical Plate System (2013), 5 descendants of its own

## Indications for use
The BC110 Pressure Manifold is intended for use with 'positive pressure' breathing gas delivery systems for pediatric patients. The device is placed upstream of the patient in-line with the circuit and contains a pressure relief valve to protect the patient from excessive inspiratory pressure in the event of a downstream occlusion. The device also provides ports to allow the connection of external pressure monitoring devices and aid oxygen analyzers. The device is intended for use with flow rates of 0-15 L/min. The relief pressure at 8 L/min is 17 cm H 20. The relief pressure at 15 L/min is 24 cm H 20. The BC110 is disposable, single patient use and is prescription only.

Source page: https://510kreport.com/device/K040366
Methodology: https://510kreport.com/methodology