DeviceClearance

Product code JOH— Anesthesiology

TRACHEOSTOMY CARE TRAY

Classification name
Tube Tracheostomy And Tube Cuff
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Total cleared
109
First cleared
Most recent

Market context for product code JOH

FDA has cleared 109 devices under product code JOH between 1976 and 2025, filed by 55 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code JOH

Adverse events under product code JOH

product code JOH
Death
42
Injury
1,344
Malfunction
5,608
Other
1
Total
6,995

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code JOH

1–100 of 109

Data sourced from openFDA. This site is unofficial and independent of the FDA.