JOHClass II

Tube Tracheostomy And Tube Cuff

21 CFR 868.5800 / Anesthesiology

JOH is the FDA product code for Tube Tracheostomy And Tube Cuff, a class II device type, regulated under 21 CFR 868.5800. As of 2026-09-10, FDA records hold 109 510(k) clearances under this code, the most recent dated 2025-12-29, and 131 recalls.

Classification record

Product code: JOH
Device name: Tube Tracheostomy And Tube Cuff
Regulation: 21 CFR 868.5800
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 109
Ingested recalls: 131

Clearances, product code JOH

By decision year

109 clearances under product code JOH with a decision year between 1976 and 2025, 1993 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code JOH by decision year
Year	Clearances
1976	1
1981	2
1989	6
1990	7
1991	6
1992	4
1993	10
1994	5
1995	4
1996	9
1997	5
1998	7
1999	1
2000	2
2001	1
2002	2
2003	4
2004	4
2005	2
2007	1
2008	2
2009	1
2010	2
2012	1
2013	3
2014	3
2015	3
2016	1
2017	1
2018	3
2019	2
2020	1
2021	2
2025	1

Applicants with the most clearances

Product code JOH

Applicants holding the most 510(k) clearances under product code JOH
Applicant	Clearances
Bivona Medical Technologies	15
Abbott Medical	9
Medtronic, Inc.	8
Mallinckrodt Medical	7
Rusch Intl.	5
Cook Inc.	4
Passy-Muir, Inc.	4
Smiths Industries Medical Systems, Inc.	4
Tracoe Medical GmbH	4
Atos Medical AB	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order