# K920908: Over the Needle Splitable Catheter Assembly Type 1

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 6, 1992 after 222 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 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
- K021034: Modified TFX Medical Safety Needle with Introducer (2002), 4 descendants of its own
- K063363: Firmgrip Peripherally Inserted Catheter Device (2007), 3 descendants of its own
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 (2004), 3 descendants of its own
- K080793: Firmgrip (2008), 2 descendants of its own
- K092629: SNM Firmgrip (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K920908
Methodology: https://510kreport.com/methodology