inforMED
OFPClass I

Anesthesia Breathing Circuit Kit (adult & Pediatric)

Anesthesiology · 21 CFR 868.5240

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events104All time
Recalls33All time
Registered firms52Currently listed
510(k) clearances0All time

Recent MDR events

104 adverse event reports on file

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Event type breakdown

Malfunction85
Injury17
Death2

Most-reported manufacturers

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Vyaire Medical15Teleflex13Drägerwerk Ag & Co. Kgaa12Westmed Llc12Smiths Medical Asd, Inc.6Vyaire Medical, Inc.4Unspecified3Flexicare Medical Dongguan Ltd.3

Recalls

33 recall events for this product code

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Registered firms

52 firms currently registered for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.