510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903437Substantially Equivalent

Dispos Access External Cardiac Pacemaker

Keller Medical Specialties Products, Inc., Antioch IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903437 is the FDA 510(k) clearance record for DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER, a class II device, cleared for Keller Medical Specialties Products, Inc. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 6 510(k) clearances for Keller Medical Specialties Products, Inc., from to . As of , FDA records show no recalls naming K903437.

Clearance record

Decision date
Received
(108 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Keller Medical Specialties Products, Inc. 42609 Crawford Rd., Antioch IL
Third party review
No

Clearances, product code DRO

Trailing 12 months

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

FDA records show no clearances under product code DRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRO, 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