510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K003701Substantially Equivalent

Sentech Medical Express Compression System (P/n Sm800)

Sentech Medical Systems, Inc., Ft Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003701 is the FDA 510(k) clearance record for SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800), a class II device, cleared for Sentech Medical Systems, Inc. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list one 510(k) clearance for Sentech Medical Systems, Inc. As of , FDA records show no recalls naming K003701.

Clearance record

Decision date
Received
(125 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Sentech Medical Systems, Inc. 5353 NW 35th Ave., Ft Lauderdale 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