# K021034: Modified TFX Medical Safety Needle with Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Tfx Medical, Inc.
- Decided: Jun 26, 2002 after 89 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851140 (1985). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851140: Teleflex Medical Introducer Needle, Teleflexmedical, Inc. (1985) Summary page 1.
- K912047: Wilson-Cook Russell Gastrostomy Kit, Wilson-Cook Medical, Inc. (1991) Summary page 1.
- K920908: Over the Needle Splitable Catheter Assembly Type 1, Teleflexmedical, Inc. (1992) Summary page 2.
- K000665: TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2000) Summary page 2.
- (no number) COOK Gastric Port System: named in the summary without a submission number
- (no number) COOK Edelman Gastrostomy Tray: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K895034: Buckys Models Ymb-15A, Ymb-15B and Ymb-15C, Yamato Medical Corp. (1989). Our reading of the summary gave K895034, FDA’s number for Buckys Models Ymb-15A, Ymb-15B and Ymb-15C (Yamato Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PUNCTUR-GUARD Blood Collection Needle”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 (2004), 3 descendants of its own
- K070449: Lumiloc (TM) Safety Introducer Needle (2007), 1 descendant of its own
- K211072: Safety Trocar Cannula (2021), 0 descendants of its own
- K180725: Aspire Introducer Needle (2018), 0 descendants of its own

## Indications for use
The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

Source page: https://510kreport.com/device/K021034
Methodology: https://510kreport.com/methodology