510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160662Substantially Equivalent

Surefire Infusion System

Surefire Medical, Inc., Westminster CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160662 is the FDA 510(k) clearance record for Surefire Infusion System, a class II device, cleared for Surefire Medical, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 10 510(k) clearances for Surefire Medical, Inc., from to . As of , FDA records show no recalls naming K160662.

Clearance record

Decision date
Received
(2 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Surefire Medical, Inc. 6272 W. 91st Ave., Westminster CO
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DQO

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