PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA— 510(k) K041348

Clearance details

Applicant

Smiths Medical

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2004-05-20

Decision date

2004-07-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hythe, Kent, GB

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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 →

• Z-1993-2021 — PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.Class II·Terminated·Smiths Medical ASD Inc.·20210514

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041348.