# K022099: Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'S

- Pathway: 510(k) (Traditional)
- Applicant: Hdc Corp.
- Decided: Sep 20, 2002 after 85 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K993191 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer, Becton Dickinson Infusion Therapy Systems, Inc. (2002) Summary page 2.
- K993191: TFX Medical Introducer Assembly, Tfx Medical, Inc. (2000) Summary page 1.
- K000665: TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2000) Summary page 1.

## Indications for use
The Safety-T-Peel Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick

Source page: https://510kreport.com/device/K022099
Methodology: https://510kreport.com/methodology