510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012417Substantially Equivalent

Hygia Health Service Reprocessed Kendall Scd Sleeve, Models # 5329, 5330, 5345, 5480

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

K012417 is the FDA 510(k) clearance record for HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480, a class II device, cleared for Hygia Health Services, Inc. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list 14 510(k) clearances for Hygia Health Services, Inc., from to . As of , FDA records show no recalls naming K012417.

Clearance record

Decision date
Received
(252 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Hygia Health Services, Inc. 2800 Milan Ct., Suite 259, Birmingham AL
510(k) summary
Summary
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JOW, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260