510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781349Substantially Equivalent

Pacer-Tracer Pulse Width

Instromedix, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781349 is the FDA 510(k) clearance record for PACER-TRACER PULSE WIDTH, a class II device, cleared for Instromedix, Inc. on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list 33 510(k) clearances for Instromedix, Inc., from to . As of , FDA records show no recalls naming K781349.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
Instromedix, Inc. 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