510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K950688Substantially Equivalent

Omin-Trak Model 3500 Series Patient Monitoring System

Safety Tek Corp., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950688 is the FDA 510(k) clearance record for OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM, a class II device, cleared for Safety Tek Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list one 510(k) clearance for Safety Tek Corp. As of , FDA records show no recalls naming K950688.

Clearance record

Decision date
Received
(429 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Safety Tek Corp. 12601 Research Pkwy., Orlando FL
510(k) summary
Statement
Third party review
No

Clearances, product code DRT

Trailing 12 months
4 clearances under product code DRT 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 DRT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260