510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071885Substantially Equivalent

Antimicrobial and Single-Patient Cuffs

Philips North America LLC, Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071885 is the FDA 510(k) clearance record for ANTIMICROBIAL AND SINGLE-PATIENT CUFFS, a class II device, cleared for Philips Medical Systems on under FDA product code OED (Antimicrobial Blood Pressure Cuff). FDA's definition for product code OED reads: "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...". FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K071885.

Clearance record

Decision date
Received
(164 days to decision)
Product code
OED Antimicrobial Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems 3000 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OED

Trailing 12 months

FDA records hold no clearances under product code OED in the trailing twelve months.

FDA records show no clearances under product code OED in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260