510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K032568Substantially Equivalent

Bp Cuff Barrier 1081789, Bp Cuff Barrier, Plastic Coated 1030193

Med Textile, LLC, Colonial Heights VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032568 is the FDA 510(k) clearance record for BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193, a class II device, cleared for Med Textile, LLC on under FDA product code DXQ (Blood Pressure Cuff). FDA's definition for product code DXQ reads: "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". FDA records list one 510(k) clearance for Med Textile, LLC. As of , FDA records show no recalls naming K032568.

Clearance record

Decision date
Received
(253 days to decision)
Product code
DXQ Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Med Textile, LLC 14300 Wood Duck Ln., Colonial Heights VA
510(k) summary
Statement
Third party review
No

Clearances, product code DXQ

Trailing 12 months
5 clearances under product code DXQ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260