Pressure Monitoring (air/gas) Kit
Anesthesiology · 21 CFR 868.2610
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.
Recent MDR events
8 adverse event reports on file
- PORTEX CUFF PRESSURE MONITORINGSep 30, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-10259
- PORTEX CUFF PRESSURE MONITORINGAug 12, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-07408
- PORTEX CUFF PRESSURE MONITORINGJun 24, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-05352
- PORTEX CUFF PRESSURE MONITORINGJun 6, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-04600
- PORTEX CUFF PRESSURE MONITORINGJun 6, 2024MalfunctionSmiths Medical Asd, Inc.3012307300-2024-04605
- MEDEX LOGICAL CABLEMay 12, 2022Malfunction3012307300-2022-08682
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMMay 11, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-08578
- PORTEX CUFF INFLATOR PRESSURE GAUGEApr 22, 2022Malfunction3012307300-2022-06851
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.