# K133528: H&H Emergency Cricothyrotomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: H & H Medical Corporation
- Decided: Jul 3, 2014 after 230 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The H & H Emergency Cricothyrotomy (cuffed) Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed. It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital. This device is intended for Limited Duration Use (<24 hours).

Source page: https://510kreport.com/device/K133528
Methodology: https://510kreport.com/methodology