510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K222158Substantially Equivalent

Capiflo 5001

K&L Distributing, Inc., Hudson FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K222158 is the FDA 510(k) clearance record for Capiflo 5001, a class II device, cleared for K&L Distributing, Inc. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list one 510(k) clearance for K&L Distributing, Inc. As of , FDA records show no recalls naming K222158.

Clearance record

Decision date
Received
(184 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
K&L Distributing, Inc. 7425 Sailfish Dr., Hudson FL
510(k) summary
Statement
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