510(k) · Cleared
ClearedPressure Manifold, Model BC 110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · CBP Valve, Non-Rebreathing
Cleared on Mar 4, 2004 as substantially equivalent to K831246 (Airlife, Inc., 1983) after a 20-day review. Its family tree reaches back 1 generation to 1983. 1 of the 25 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Mar 4, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831246 (1983). 23 later devices descend from it, 3 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK831246 Whistler in-Line Pressure Release ValveAirlife, Inc. · 1983
- This deviceK040366 Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd. · 2004
- Descendant · cites it directly · 19 of its ownK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- Descendant · 2 generations on · 12 of its ownK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- Descendant · 3 generations on · 11 of its ownK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
- Descendant · 3 generations on · 5 of its ownK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K110383 Babi*Plus Pressure Relief Manifold - 10CM H20…cites it directly · 2011
Most influential descendants
Showing 5 of 23 · See all- K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008 · cites it directly19descendants
- K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010 · 2 generations on12descendants
- K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011 · 3 generations on11descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 2 generations on5descendants
- K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831246 | Whistler in-Line Pressure Release Valve | Airlife, Inc. | 1983 | — |
| 0 (this device) | K040366 | Pressure Manifold, Model BC 110 | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +1 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| +2 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| +3 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| +2 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
| +3 | K130427 | Pioneer Aspect Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K831246 | Whistler in-Line Pressure Release ValveSummary page 1…Anesthesiology, 21 CFR §868.5870 (Class II) Predicate Device: AirLife Inc. Whistler In-line Pressure Release Valve K831246 Classification Name: Non-rebreathing valve-73 CBP Anesthesiology, 21 CFR §868.5870 (… | 1983 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K072703 (Pioneer Surgical Technology, 2008) has gone furthest, with 19 descendants of its own.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040366: Pressure Manifold, Model BC 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026