510(k) · Cleared
ClearedOne Way Soft Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · MJJ Cpb Check Valve, Retrograde Flow, In-Line
Cleared on Jan 29, 2015 as substantially equivalent to K922356 (American Omni Medical, Inc., 1993) after a 146-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 29, 2015
- Review
- 146 days
- Class
- Class II
- Product code
- MJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922356 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK922356 Flow Control Valve, Cat. NO. Acv-38American Omni Medical, Inc. · 1993
- This deviceK142500 One Way Soft ValveTerumo Cardiovascular Systems Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922356 | Flow Control Valve, Cat. NO. Acv-38 | American Omni Medical, Inc. | 1993 | — |
| 0 (this device) | K142500 | One Way Soft Valve | Terumo Cardiovascular Systems Corporation | 2015 | — |
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 MJJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K922356 | Flow Control Valve, Cat. NO. Acv-38Summary page 5…equivalent in indications for use, design, technology including features, materials, and principles of operation to the Quest Medical Retroguard Arterial Safety Valve — K922356. Device Description: The One Way Soft Valve is a transparent one-way valve with %” inlet and outlet ports. The One Way Soft Val… | 1993 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K922356.
How does its category compare?
All MJJ devicesMJJ Cpb Check Valve, Retrograde Flow, In-Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MJJ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MJJ
Too few MJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MJJ
36in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJJ
1in 2019
MAUDE reports naming product code MJJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 36 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The One Way Soft Valve is intended to be used for the prevention of retrograde flow in ¼” or smaller lines subject to arterial pressure during cardiopulmonary bypass procedures for use up to six hours.
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/K142500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142500: One Way Soft Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142500
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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