# K010016: Melker Cuffed Emergency Cricothyrotomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 9, 2001 after 280 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
No predicates in its family tree.
9 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013916: Melker Emergency Cricothyrotomy Catheter Set (2001), 2 descendants of its own
- K160200: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (2017), 1 descendant of its own
- K013252: Patil Emergency Cricothyrotomy Catheter Set (2002), 1 descendant of its own
- K200190: ScalpelCric (2020), 0 descendants of its own
- K153761: Emergency Transtracheal Airway Catheter (2016), 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.

Source page: https://510kreport.com/device/K010016
Methodology: https://510kreport.com/methodology