510(k) · Cleared
ClearedSeal Rite Non-Rebreathing Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Lifeguard Store, Inc. · CBP Valve, Non-Rebreathing
Cleared on Jun 3, 2016 as substantially equivalent to K833748 (Respironics, Inc., 1983) after a 274-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.
- Decided
- Jun 3, 2016
- Review
- 274 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833748 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK833748 Rescue ValveRespironics, Inc. · 1983
- This deviceK152521 Seal Rite Non-Rebreathing ValveThe Lifeguard Store, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171961 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen…Xiamen Compower Medical Tech. Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…Xiamen Compower Medical Tech. Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833748 | Rescue Valve | Respironics, Inc. | 1983 | — |
| 0 (this device) | K152521 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | 2016 | — |
| +1 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port… | Xiamen Compower Medical Tech. Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K833748 | Rescue ValveSummary page 4…tion 21 CFR 868.5870 Type of 510(k) Submission Traditional Legally Marketed Predicate Device Respironics Rescue Valve (K833748) Description The Seal Rite™ Non-Rebreathing Valve (“Seal Rite Valve”) is a resuscitation valve designed for resu… | 1983 |
| † | K142402 | BigEasy Non-Rebreathing Valve | 2015 |
| † | K842693 | Respironics Venteasy | 1984 |
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 |
|---|---|---|---|
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower… | 2017 | 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?
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152521: Seal Rite Non-Rebreathing Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152521
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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