# K173955: Mic-Key* SF Over-the-Wire Stoma Measuring Device

- Pathway: 510(k) (Special)
- Applicant: Halyard Health, Inc.
- Decided: Jan 26, 2018 after 29 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: 3 generations back to K922667 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122653: Mic-Key SF Low Profile Gastrostomy Tube and Accessories, Kimberly-Clark Corporation (2013) Summary page 4.

## Indications for use
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.

Source page: https://510kreport.com/device/K173955
Methodology: https://510kreport.com/methodology