JOH · Class II · 21 CFR 868.5800

FDA Product Code JOH: Tube Tracheostomy And Tube Cuff

Leading manufacturers include Smiths Medical Asd, Inc. and Covidien, LLC.

109
Total
109
Cleared
152d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 245d recently vs 151d historically

FDA 510(k) Cleared Tube Tracheostomy And Tube Cuff Devices (Product Code JOH)

109 devices
1–24 of 109
Cleared Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula
K251313
Covidien, LLC
Anesthesiology · 245d
Cleared Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
K210833
Smiths Medical Asd, Inc.
Anesthesiology · 252d

About Product Code JOH - Regulatory Context

510(k) Submission Activity

109 total 510(k) submissions under product code JOH since 1976, with 109 receiving FDA clearance (average review time: 152 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under JOH have taken an average of 245 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.

JOH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →