# K200190: ScalpelCric

- Pathway: 510(k) (Traditional)
- Applicant: VBM Medizintechnik GmbH
- Decided: Oct 30, 2020 after 277 days
- Product code: BWC (Needle, Emergency Airway)
- Device class: 2
- Regulation: 21 CFR 868.5090
- 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 K010016 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160200: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set, Cook Incorporated (2017) Summary page 7.

## Indications for use
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.

Source page: https://510kreport.com/device/K200190
Methodology: https://510kreport.com/methodology