# K934123: Stopcock (One-Port Manifold)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 23, 1993 after 90 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 3 cite it directly.
1 of 79 devices in its family (counting itself) has 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.

## Most influential descendants
- K023272: Disposable Aspiration Needle NA-200H (2002), 63 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K100712: Resound Endoscopic Ultrasound Aspiration Needle (2010), 27 descendants of its own
- K110030: Expect Endoscopic Aspiration Needle (2011), 26 descendants of its own
- K112198: Expect Endoscopic Ultrasound Aspiration Needle (2011), 16 descendants of its own

## Recalls of this device
- Feb 13, 2003 · Not classified · Z-0620-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0621-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0622-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

Source page: https://510kreport.com/device/K934123
Methodology: https://510kreport.com/methodology