510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131966Substantially Equivalent

Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System

Twin Star Medical, Inc., Minnetonka MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131966 is the FDA 510(k) clearance record for TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM, cleared for Twin Star Medical, Inc. on under FDA product code LXC (Monitor, Pressure, Intracompartmental). FDA records list 4 510(k) clearances for Twin Star Medical, Inc., from to . As of , FDA records show no recalls naming K131966.

Clearance record

Decision date
Received
(224 days to decision)
Product code
LXC Monitor, Pressure, Intracompartmental
Device class
Unclassified
Review panel
Unknown
Applicant
Twin Star Medical, Inc. 5116 Birch Rd., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXC

Trailing 12 months
1 clearance under product code LXC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LXC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260