# K982797: Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

- Pathway: 510(k) (Traditional)
- Applicant: Luther Medical Products, Inc.
- Decided: Nov 30, 1998 after 112 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
Longest line of descent: 1 generation back to K895024 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924562: Catheter Introducer, Luther Medical Products, Inc. (1993) Summary page 1.
- K895024: Punctur-Guard (TM) Blood Collection Needle, Bio-Plexus, Inc. (1990) Summary page 1.

## Indications for use
The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.

Source page: https://510kreport.com/device/K982797
Methodology: https://510kreport.com/methodology