Needle, Emergency Airway
Anesthesiology · 21 CFR 868.5090
Recent MDR events
22 adverse event reports on file
- MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETJan 5, 2026MalfunctionCook Inc1820334-2026-00006
- PORTEX EMERGENCY CRICOTHYROIDOTOMY KITJan 24, 2024MalfunctionSmiths Medical Czech Republic A. S3011237704-2024-00024
- MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETDec 8, 2022MalfunctionCook Inc1820334-2022-01827
- PORTEX CRICOTHYROIDOTOMYSep 13, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-18871
- PORTEX EMERGENCY CRICOTHYROIDOTOMY KITAug 16, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-15429
- MELKER EMERGENCY CRICOTHYROTOMY CATHETERJun 8, 2022DeathCook Inc1820334-2022-01009
- MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SETDec 1, 2021InjuryCook Inc1820334-2021-02614
- UNKNOWNSep 4, 2019MalfunctionCook Inc1820334-2019-02216
- MELKER EMERGENCY CRICOTHYROTOMY CATHETER SETAug 20, 2018InjuryCook Inc1820334-2018-02219
- ARNDT ENDOBRONCHIAL BLOCKER SETJun 12, 2018MalfunctionCook Inc1820334-2018-01678
Event type breakdown
Recalls
2 recall events for this product code
- Cook IncorporatedOpen, ClassifiedApr 6, 2026
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193;
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1785-2026 · View FDA record ↗ - Tytek Medical IncTerminatedFeb 12, 2020
PneumoDart, 14 ga x 3.25in., REF TM-317
A defect involving an occluded needle was discovered during a training exercise.
Z-0930-2020 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Platinum Focus Group Ltd.
London London, City of, GB
Cook Incorporated
Bloomington, IN, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Ad Supply Group Limited
London London, City of, GB
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Cbr Enterprise Limited
Hong Kong, HK
Ffrench Pocket Emergency Airway, Inc.
Carrollton, LA, US
Vbm Medizintechnik Gmbh
SULZ AM NECKAR Baden-Wurttemberg, DE
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Pharmco Medical Bv
ROTTERDAM Zuid-Holland, NL
Icu Medical Nederland B.v.
Wijchen Gelderland, NL
Cook Incorporated
ELLETTSVILLE, IN, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Ha2 Medizintechnik Gmbh
Halberstadt Saxony-Anhalt, DE
Icu Medical Czech Republic A. S.
Hranice Olomoucky Kraj, CZ
510(k) clearances
14 clearances for this product code
- VBM Medizintechnik GmbHOct 30, 2020
K200190 · ScalpelCric
- Cook IncorporatedFeb 17, 2017
K160200 · Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- Cook IncorporatedSep 22, 2016
K153761 · Emergency Transtracheal Airway Catheter
- Teleflex MedicalNov 6, 2013
K130405 · RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
- Smiths MedicalMay 26, 2005
K050166 · PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
- Cook, Inc.Feb 21, 2002
K013241 · ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
- Cook, Inc.Feb 21, 2002
K013252 · PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
- Cook, Inc.Dec 20, 2001
K013916 · MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET