510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010634Substantially Equivalent

Heartstream Xl Defibibrillator/monitor, Model M4735a, Heartstream Xlt Defibrillator/monitor.model M2500b

Agilent Technologies, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010634 is the FDA 510(k) clearance record for HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B, a class III device, cleared for Agilent Technologies, Inc. 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 51 510(k) clearances for Agilent Technologies, Inc., from to . As of , FDA records show one recall naming K010634.

Clearance record

Decision date
Received
(101 days to decision)
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Regulation
21 CFR 870.5310
Device class
Class III
Review panel
Cardiovascular
Applicant
Agilent Technologies, Inc. 3000 Minuteman Rd., Andover MA
510(k) summary
Summary
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