510(k) · Cleared
ClearedOJR215 Pressure Relief Manifold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare Limited · CBP Valve, Non-Rebreathing
Cleared on Apr 5, 2019 after a 480-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Apr 5, 2019
- Review
- 480 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK173770 OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare Limited · 2019
- Descendant · cites it directly · 0 of its ownK234053 F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019 | — |
| +1 | K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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.
Planning a device in CBP? 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234053 | F&P Optiflow Flow Diverter | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K234053 (Fisher & Paykel Healthcare, Ltd., 2024) has gone furthest, with 0 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. 2019, this device’s year, is highlighted.
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 OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula. The device is intended for use with flow rates greater than 0.5 L/min up to, and including, 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only. The OJR215…
Read the full statement (144 words)
The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula.
The device is intended for use with flow rates greater than 0.5 L/min up to, and including, 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.
The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula.
The device is intended for use with flow rates greater than 0.5 L/min up to, and including, 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173770: OJR215 Pressure Relief Manifold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173770
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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