510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163620Substantially Equivalent

Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves

Medtronic, Inc., Mansfield MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163620 is the FDA 510(k) clearance record for Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves, a class II device, cleared for Covidien on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K163620.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Covidien 15 Hampshire Stree, Mansfield MA
510(k) summary
Summary PDF
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