DeviceClearance

Product code OED— Cardiovascular

ANTIMICROBIAL AND SINGLE-PATIENT CUFFS

Classification name
Antimicrobial Blood Pressure Cuff
Device class
Class 2
Regulation
21 CFR 870.1120
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code OED under 21 CFR 870.1120, via openFDA

Market context for product code OED

FDA has cleared 2 devices under product code OED between 2007 and 2013, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OED

Recent clearances under product code OED

Data sourced from openFDA. This site is unofficial and independent of the FDA.