510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800286Substantially Equivalent

Criterion II Pacing System Monitors

Dart Medical Equipment, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800286 is the FDA 510(k) clearance record for CRITERION II PACING SYSTEM MONITORS, a class II device, cleared for Dart Medical Equipment on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list 7 510(k) clearances for Dart Medical Equipment, from to . As of , FDA records show no recalls naming K800286.

Clearance record

Decision date
Received
(33 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
Dart Medical Equipment 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTC

Trailing 12 months

FDA records hold no clearances under product code DTC in the trailing twelve months.

FDA records show no clearances under product code DTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260