FDA product code JOH: Tube Tracheostomy And Tube Cuff

JOH is the FDA product code for tube tracheostomy and tube cuff. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel. FDA has cleared 109 510(k) submissions under JOH, 1 in the last five years, from 55 different applicants. The average 510(k) review took 152 days (median 118); 245 days on average over the last three years. FDA has posted 131 recalls for JOH devices, 10 initiated in the last five years.

Classification

Field	Value
Device name	Tube Tracheostomy And Tube Cuff
Device class	Class II
Regulation	21 CFR 868.5800
Review panel	AN — Anesthesiology
Medical specialty	Anesthesiology
Premarket route	510(k)
Life-sustaining or supporting	Yes
Third-party 510(k) review eligible	Yes

510(k) clearances per year for JOH

Year	Clearances	Avg. review days
2017	1	273
2018	3	164
2019	2	96
2020	1	209
2021	2	257
2025	1	245

Compare with all 510(k) review times · Search every JOH clearance

Top JOH applicants

Applicant	Clearances	Latest
Bivona Medical Technologies	15	1995-10-31
Mallinckrodt Medical	7	2005-06-16
Covidien	6	2020-06-01
Smiths Medical Asd, Inc.	5	2021-11-26
Rusch Intl.	5	2003-03-28

50 more applicants have JOH clearances. See the full list in Caduvo.

Most recent JOH clearances

510(k)	Applicant	Device	Decision date	Review days
K251313	Covidien, LLC	Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT	2025-12-29	245
K210833	Smiths Medical Asd, Inc.	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula	2021-11-26	252
K203362	Tracoe Medical GmbH	TRACOE vario	2021-08-05	262
K193077	Covidien	Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff	2020-06-01	209
K193133	Cook Incorporated	Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set	2019-12-12	30

Recalls for JOH devices

131 product recalls in 32 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-04-15.

Year	Recalls
2017	2
2020	3
2021	2
2023	4
2025	1
2026	5

Frequently asked questions

What is FDA product code JOH?

JOH is the FDA product code for tube tracheostomy and tube cuff. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel.

What device class is JOH?

Class II, regulation 21 CFR 868.5800. Typical premarket route: 510(k).

How long does a 510(k) take for product code JOH?

Across 109 cleared submissions the average was 152 days from receipt to decision (median 118).

Which companies have the most JOH clearances?

Bivona Medical Technologies (15); Mallinckrodt Medical (7); Covidien (6); Smiths Medical Asd, Inc. (5); Rusch Intl. (5).

Have JOH devices been recalled?

Yes: 131 product recalls across 32 recall events; the most recent began 2026-04-15.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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