# K992664: TFX Medical Stylet Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Tfx Medical Group
- Decided: Apr 13, 2000 after 248 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lake Region Stylet: named in the summary without a submission number

## Most influential descendants
- K182660: GaltTWS (2019), 1 descendant of its own
- K220280: Arrow Stiffening Stylet (2022), 0 descendants of its own

## Indications for use
This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.

Source page: https://510kreport.com/device/K992664
Methodology: https://510kreport.com/methodology