PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA— 510(k) K960429

Clearance details

Applicant

Smiths Industries Medical Systems, Inc.

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

1996-01-31

Decision date

1996-05-02

Decision

Unknown

Clearance type

Traditional

Location

Keene, NH, US

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• K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED1998-01-20
• K965017 — REGIONAL ANESTHESIA TRAYS1997-03-14
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• K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT1996-10-21
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Death

42

Injury

1,344

Malfunction

5,608

Other

1

Total

6,995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →