Anesthesia Breathing Circuit Kit (Adult & Pediatric)
The Anesthesia Breathing Circuit Kit for Adult and Pediatric Use (product code OFP) is an anesthesiology convenience kit containing components of an anesthesia breathing circuit, including tubing, connectors, and related accessories for delivering inhaled anesthesia to patients. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission if all guidance criteria are met. This device is FDA Class 1 under regulation 868.5240 in the Anesthesiology specialty, subject only to general controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OFP
- Device Class
- FDA class 1
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.