510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852905Substantially Equivalent

Cr 280/45, Cr281/4 Defibrillator

Cardiac Recorders, Ltd., London, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852905 is the FDA 510(k) clearance record for CR 280/45, CR281/4 DEFIBRILLATOR, a class II device, cleared for Cardiac Recorders, Ltd. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 8 510(k) clearances for Cardiac Recorders, Ltd., from to . As of , FDA records show no recalls naming K852905.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiac Recorders, Ltd. 34 Scarborough Rd., London, GB
Third party review
No

Clearances, product code LDD

Trailing 12 months

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

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