# K122653: Mic-Key SF Low Profile Gastrostomy Tube and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corporation
- Decided: Jun 26, 2013 after 299 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922667 (1993). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043114: Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube, Kimberly-Clark Corp. (2004) Summary page 1.
- K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit, Ballard Medical Products (1999) Summary page 1.

## Most influential descendants
- K161413: Low Profile Balloon Feeding Device (2017), 1 descendant of its own
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own
- K173955: Mic-Key* SF Over-the-Wire Stoma Measuring Device (2018), 0 descendants of its own

## Recalls of this device
- Jul 29, 2020 · Class II · Z-2969-2020: Devices had cracked or detached from the feeding tube body

## Indications for use
The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression. Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression. Kimberly-Clark* MIC-KEY* SF Patient Starter Kit is indicated to provide necessary components to begin enteral feeding after placement of the Kimberly-Clark* MIC-KEY* SF Gastrostomy Tube. Kimberly-Clark* 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/K122653
Methodology: https://510kreport.com/methodology