# K913746: Smartneedle (TM) Vascular Access System

- Pathway: 510(k) (Traditional)
- Applicant: Peripheral Systems Group
- Decided: Dec 17, 1991 after 118 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device (1997), 2 descendants of its own
- K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (1998), 1 descendant of its own
- K090743: Yield Mini Doppler System (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K913746
Methodology: https://510kreport.com/methodology