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
K982264Substantially Equivalent - Subject to Tracking Reg.

Firstsave Biphasic Models 9200 and 9210

Survivalink Corp., Minnetonka MN / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K982264 is the FDA 510(k) clearance record for FIRSTSAVE BIPHASIC MODELS 9200 AND 9210, a class III device, cleared for Survivalink Corp. on under FDA product code MKJ (Automated External Defibrillators (Non-Wearable)). FDA's definition for product code MKJ reads: "This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an...". FDA records list 7 510(k) clearances for Survivalink Corp., from to . As of , FDA records show no recalls naming K982264.

Clearance record

Decision date
Received
(210 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Survivalink Corp. 5420 Feltl Rd., Minnetonka MN
Third party review
No

Clearances, product code MKJ

Trailing 12 months

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

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