Antimicrobial Blood Pressure Cuff
Cardiovascular · 21 CFR 870.1120
Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Recent MDR events
18 adverse event reports on file
- NIBP CUFFSJul 2, 2026MalfunctionPhilips Medical Systems1218950-2026-100463
- NIBP CUFFSJun 17, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101168
- NIBP CUFFSMay 15, 2026InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100954
- NIBP CUFFSApr 14, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100700
- NIBP CUFFSMar 24, 2026MalfunctionPhilips Medical Systems1218950-2026-100170
- NIBP CUFFSMar 9, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100473
- NIBP CUFFSMar 5, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100447
- NIBP CUFFSMar 2, 2026MalfunctionPhilips Medical Systems1218950-2026-100097
- NIBP CUFFSJan 7, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-100017
- EASY CARE CUFF, 1 HOSE, ADULT (1)Sep 16, 2025InjuryPhilips Medical Systems1218950-2025-000534
Event type breakdown
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Trend for “Failure to Deflate”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Philips North America Llc
Cambridge, MA, US
Spacelabs Healthcare Inc.
Snoqualmie, WA, US
Philips North America Llc
ANDOVER, MA, US
Iimed Medical Mexicana S. De R.l. De C.v.
Reynosa Tamaulipas, MX
Philips Medical Systems Ltda
Varginha Minas Gerais, BR
Philips Electronics Ltd
Mississauga Ontario, CA
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Gregory Mfg., Inc.
Holyoke, MA, US
510(k) clearances
2 clearances for this product code