# K001245: 3T L. V. Control Valve

- Pathway: 510(k) (Traditional)
- Applicant: 3t Medical Systems, LLC
- Decided: Aug 15, 2001 after 484 days
- Product code: MJJ (Cpb Check Valve, Retrograde Flow, In-Line)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 11, 2011 · Not classified · Z-3228-2011: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.

Source page: https://510kreport.com/device/K001245
Methodology: https://510kreport.com/methodology