# K010634: Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT Defibrillator/Monitor.Model M2500B

- Pathway: 510(k) (Traditional)
- Applicant: Agilent Technologies, Inc.
- Decided: Jun 11, 2001 after 101 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 25, 2002 · Not classified · Z-0343-03: Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.

Source page: https://510kreport.com/device/K010634
Methodology: https://510kreport.com/methodology