# K851986: Stopcocks

- Pathway: 510(k) (Traditional)
- Applicant: Transamerica Delaval, Inc.
- Decided: May 23, 1985 after 16 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 10 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 9, 2004 · Not classified · Z-0235-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0237-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0239-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0234-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0242-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0236-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0238-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0240-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0241-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0243-05: Sterility of the device is compromised due to packaging defects

Source page: https://510kreport.com/device/K851986
Methodology: https://510kreport.com/methodology