# K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: May 8, 2002 after 14 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941811 (1994). 36 ancestors in all.
421 later devices descend from it; 4 cite it directly.
0 of 458 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B, Philips Medical Systems, Inc. (2001) Summary page 2.
- K990125: HP Viridia Component Monitoring System, Model Rev. K, Hewlett-Packard GmbH (1999) Summary page 2.
- K951127: Hewlett-Packard Model M1026A Anesthetic Gas Module, Hewlett-Packard GmbH (1995) Summary page 2.
- K982619: HP Anesthesia Gas Monitor (Watertrap), Model A02, Hewlett-Packard Co. (1998) Summary page 2.
- K994188: Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5, Agilent Technologies, GmbH (2000) Summary page 2.
- K971910: Multi-Parameter Module (M3000A)/Display Unit (M3046A), Hewlett-Packard GmbH (1998) Summary page 2.

## Most influential descendants
- K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B (2002), 407 descendants of its own
- K023871: M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology (2002), 406 descendants of its own
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr (2003), 404 descendants of its own
- K031481: The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 (2003), 376 descendants of its own
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. (2003), 375 descendants of its own

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. EASTI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO02) is restricted to neonatal patients only.

Source page: https://510kreport.com/device/K021300
Methodology: https://510kreport.com/methodology
