TRACHEAL TUBE W/ILLUMINATING LOCATER— 510(k) K830631

Clearance details

Applicant

Mallinckrodt Critical Care

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

1983-03-01

Decision date

1983-05-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K251794 — Tenax® Laser Resistant Endotracheal Tube2026-09-03
• K253437 — Spiro-VISTA2026-06-12
• K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)2025-10-06
• K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced2025-09-25
• K243579 — AeroJet Ventilation Catheter2025-08-13

• K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
• K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR1988-02-02
• K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
• K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
• K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

Death

92

Injury

1,263

Malfunction

7,475

Other

2

Total

8,832

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 →