Laryngoscope Kit
Anesthesiology · 21 CFR 868.5540
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Recent MDR events
18 adverse event reports on file
- KIT: CIRCUMCISION 20/CSMay 18, 2026InjuryMedical Action Industries1030451-2026-00020
- LAYRNG-O-JET KITJun 21, 2021InjuryMW5101996
- LARYNGOSCOPE ADAPTERFeb 11, 2020InjuryAmbuusa / King Systems CorporationMW5092935
- LARYNG-O JET KITOct 7, 2019InjuryUnkMW5090270
- KING VISION VIDEO LARYNGOSCOPEAug 15, 2018InjuryAmbu / King SystemsMW5079168
- KING VISIONApr 1, 2016InjuryKing Systems (ambu)MW5061451
- RUSCH MRI COND FIBER OPTIC LARYN KITSep 14, 2015MalfunctionTeleflex Medical1044475-2015-00371
- RUSCH MRI COND FIBER OPTIC LARYN KITAug 19, 2015MalfunctionTeleflex Medical1044475-2015-00311
- RUSCH MRI COND FIBER OPTIC LARYN KITJul 1, 2015MalfunctionTeleflex Medical1044475-2015-00215
- RUSCH MRI COND FIBER OPTIC LARYN KITJul 1, 2015MalfunctionTeleflex Medical1044475-2015-00216
Event type breakdown
Recalls
4 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedFeb 10, 2025
Cardinal Health Presource Kits:
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Z-1131-2025 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedJan 15, 2025
Cardinal Health Presource Kits:
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Z-0912-2025 · View FDA record ↗ - Flexicare Medical Ltd.TerminatedJan 13, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(1
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Z-0803-2020 · View FDA record ↗ - Flexicare Medical Ltd.TerminatedJan 13, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Z-0804-2020 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Ontario, CA, US
Hilbro International (pvt) Limited
SIALKOT Punjab, PK
Honduras Kitting, S.a.
Villanueva Cortes, HN
Integra Lifesciences Corporation
Princeton, NJ, US
Britemed Technology Inc.
New Taipei City, TW
Bound Tree Medical, Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
Ambu A/s
Ballerup Hovedstaden, DK
Cardinal Health 200, Llc
El Paso, TX, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Isomedix Operations Inc
EL PASO, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.