510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090308Substantially Equivalent

Restep Dvy System, Model Rsp-101

Stortford Medical, LLC, West Windsor NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090308 is the FDA 510(k) clearance record for RESTEP DVY SYSTEM, MODEL RSP-101, a class II device, cleared for Stortford Medical, LLC on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list 2 510(k) clearances for Stortford Medical, LLC, from to . As of , FDA records show one recall naming K090308.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Stortford Medical, LLC 295 Princeton Hightstown Rd., Unit 321, West Windsor NJ
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