# K982025: Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Sep 4, 1998 after 87 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895520 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951593: Lifepak 11, Physio-Control Corp. (1995) Summary page 1.
- K912189: Likepak 11 Cardiac Monit/Lifenet RS100 Rec Station, Physio-Control Corp. (1992) Summary page 1.
- K935772: HP M177XA Cardiographs, Hewlett-Packard Co. (1994) Summary page 1.
- K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio, Hewlett-Packard Co. (1996) Summary page 1.
- K981265: Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time Insensitive Predictive Instrumena, Hewlett-Packard Co. (1998). Cleared while this submission was under review Summary page 1.

## Indications for use
The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use. The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac arrhythmias. The 12-Lead feature can also be applied to patients for routine. medical examinations or anytime a baseline ECG is ordered by a physician. Note that a physician must review the preliminary report. Like any computer assisted ECG interpretation program, the predictive instrument evaluation is not a substitute for the physician’s decision process. This product is not intended for home use.

Source page: https://510kreport.com/device/K982025
Methodology: https://510kreport.com/methodology