510(k) · Cleared
ClearedBigEasy Non-Rebreathing Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
12th Man Technologies, Inc. · CBP Valve, Non-Rebreathing
Cleared on Mar 23, 2015 as substantially equivalent to K833748 (Respironics, Inc., 1983) and 1 other predicate after a 208-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Mar 23, 2015
- Review
- 208 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833748 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK833748 Rescue ValveRespironics, Inc. · 1983
- This deviceK142402 BigEasy Non-Rebreathing Valve12th Man Technologies, Inc. · 2015
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) | K142402 | BigEasy Non-Rebreathing Valve | 12th Man Technologies, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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? (2)
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…on Traditional Legally Marketed Equivalent Respironics Rescue Valve/VentEasy Non- Rebreathing Valve (K8337480 and K842693) Description The BigEasyTM Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired… | 1983 |
| * | K842693 | Respironics VenteasySummary page 4…Traditional Legally Marketed Equivalent Respironics Rescue Valve/VentEasy Non- Rebreathing Valve (K8337480 and K842693) Description The BigEasyTM Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for vent… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K833748.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142402 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142402: BigEasy Non-Rebreathing Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142402
Report an extraction error
Are you the manufacturer?
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