# K160200: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 17, 2017 after 386 days
- Product code: BWC (Needle, Emergency Airway)
- Device class: 2
- Regulation: 21 CFR 868.5090
- 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: 1 generation back to K010016 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010016: Melker Cuffed Emergency Cricothyrotomy Catheter, Cook, Inc. (2001) Summary page 4.

## Most influential descendants
- K200190: ScalpelCric (2020), 0 descendants of its own

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1785-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

## Indications for use
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane. The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane. The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

Source page: https://510kreport.com/device/K160200
Methodology: https://510kreport.com/methodology