510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K872778Substantially Equivalent

Pacestart

Pacific Rim Engineering & Mfg., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872778 is the FDA 510(k) clearance record for PACESTART, a class II device, cleared for Pacific Rim Engineering & Mfg. on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list one 510(k) clearance for Pacific Rim Engineering & Mfg. As of , FDA records show no recalls naming K872778.

Clearance record

Decision date
Received
(113 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
Pacific Rim Engineering & Mfg. 2227 Faraday Suite A, Carlsbad CA
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