510(k) · Cleared
Recalled · 20113T L. V. Control Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3t Medical Systems, LLC · MJJ Cpb Check Valve, Retrograde Flow, In-Line
Cleared on Aug 15, 2001 after a 484-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 36 times.
- Decided
- Aug 15, 2001
- Review
- 484 days
- Class
- Class II
- Product code
- MJJ
- Recalls
- 36
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2011 | Not classified | Z-3228-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3238-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3223-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3250-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3226-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3243-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3222-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3235-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3239-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3234-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3237-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3247-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3230-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3233-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3246-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3232-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3249-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3244-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3240-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3227-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3231-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3236-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3252-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3229-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3242-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3245-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3248-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3224-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3251-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3225-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Aug 11, 2011 | Not classified | Z-3241-2011 | Nonconforming Material/Component | 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves |
| Jul 21, 2011 | Not classified | Z-3060-2011 | Other | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
| Jul 21, 2011 | Not classified | Z-3058-2011 | Other | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
| Jul 21, 2011 | Not classified | Z-3062-2011 | Other | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
| Jul 21, 2011 | Not classified | Z-3059-2011 | Other | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
| Jul 21, 2011 | Not classified | Z-3061-2011 | Other | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. |
The 5 latest of 36 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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.
FDA decisions per year · MJJ
1in 2018
2007high 1 (2015) · low 0 (2007)2026
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
2007high 36 (2011) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJJ
1in 2019
2007high 4 (2018) · low 0 (2007)2025
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 | — |
https://510kreport.com/device/K001245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001245: 3T L. V. Control Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001245
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026