510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K891122Substantially Equivalent

Disp. Accessory to External Trans. Cardiac Pace.

Big Valley Medical, Orangevale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891122 is the FDA 510(k) clearance record for DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE., a class II device, cleared for Big Valley Medical on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list one 510(k) clearance for Big Valley Medical. As of , FDA records show no recalls naming K891122.

Clearance record

Decision date
Received
(195 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
Big Valley Medical P.O. Box 1892, Orangevale CA
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