510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OFPClass I

Anesthesia Breathing Circuit Kit (Adult & Pediatric)

21 CFR 868.5240 / Anesthesiology
FDA source (opens on fda.gov)

OFP is the FDA product code for Anesthesia Breathing Circuit Kit (Adult & Pediatric), a class I device type, regulated under 21 CFR 868.5240. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 33 recalls.

Classification record

Product code
OFP
Device name
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
FDA definition
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.
Regulation
21 CFR 868.5240
Device class
Class I
Review panel
Anesthesiology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
33

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order