# K963120: Responder 2500 Defibrillator and Cardiac Care System

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Feb 28, 1997 after 200 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Marquette Series 900: named in the summary without a submission number
- (no number) Marquette Series 1500 Responder: named in the summary without a submission number

## Indications for use
Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias. Responder 2500 is intended to be used by trained operators Responder 2500 is designed for external and internal defibrillation (including cardioversion) Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits. Responder 2500 is designed for external pacing with adjustable current and rate.

Source page: https://510kreport.com/device/K963120
Methodology: https://510kreport.com/methodology