Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula— 510(k) K210833

Clearance details

Applicant

Smiths Medical Asd, Inc.

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2021-03-19

Decision date

2021-11-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plymouth, MN, US

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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 →