COLIBRI— 510(k) K940041

Clearance details

Applicant

Icor AB

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

1994-01-04

Decision date

1994-07-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bromma, SE

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• 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

• K954402 — ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)1996-05-22
• K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
• K952325 — ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)1995-07-31
• K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE1995-07-13
• K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS1994-08-15

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 →