# K101199: Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter,

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Aug 27, 2010 after 120 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: 2 generations back to K831840 (1983). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831840: Feeding Tube Placement Stylet, Biosearch Medical Products, Inc. (1983) Summary page 2.
- K894857: Pedi-Tube (R) Stylet, Biosearch Medical Products, Inc. (1989) Summary page 2.
- K960632: Kangaroo Feeding Tube Placment Stylet, Sherwood Medical Co. (1996) Summary page 2.
- K920884: Guidewires, Various Types, Acme-Monaco Corp. (1992) Summary page 2.

## Most influential descendants
- K153461: Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm (2015), 0 descendants of its own

## Indications for use
The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.

Source page: https://510kreport.com/device/K101199
Methodology: https://510kreport.com/methodology