510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895729Substantially Equivalent

R2 Pace Pad, Model 480

Darox Corp., Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895729 is the FDA 510(k) clearance record for R2 PACE PAD, MODEL 480, a class II device, cleared for Darox Corp. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 2 510(k) clearances for Darox Corp. As of , FDA records show one recall naming K895729.

Clearance record

Decision date
Received
(17 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
Darox Corp. 5731 W. Howard Ave., Niles 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