510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032821Substantially Equivalent

Hygia Health Services Reprocessed Blood Pressure Cuff

Hygia Health Services, Inc., Birmingham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032821 is the FDA 510(k) clearance record for HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF, a class II device, cleared for Hygia Health Services, Inc. on under FDA product code NPP (Reprocessed Blood Pressure Cuff). FDA's definition for product code NPP reads: "The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with...". FDA records list 14 510(k) clearances for Hygia Health Services, Inc., from to . As of , FDA records show no recalls naming K032821.

Clearance record

Decision date
Received
(91 days to decision)
Product code
NPP Reprocessed Blood Pressure Cuff
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Applicant
Hygia Health Services, Inc. 434 Industrial Ln., Birmingham AL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPP

Trailing 12 months

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

FDA records show no clearances under product code NPP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPP, 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