# K021778: Philips Component Compact Monitor, Release a.04, Model #M1275B

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jul 17, 2002 after 48 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941811 (1994). 47 ancestors in all.
407 later devices descend from it; 31 cite it directly.
0 of 455 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.
- K020531: Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B, Philips Medical Systems (2002) Summary page 2.
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B, Philips Medical Systems (2002) Summary page 2.
- K990125: HP Viridia Component Monitoring System, Model Rev. K, Hewlett-Packard GmbH (1999) Summary page 2.
- K992674: HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027A, Hewlett-Packard GmbH (1999) Summary page 2.
- K003038: Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model M1175A/76A/77A,Rev.L,M1205A,Rev.L,M1034A, Agilent Technologies Deutschland GmbH (2000) Summary page 2.
- K021422: Philips Information Center Software Revision D.02, Philips Medical Systems (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K942843: Cervex-Brush (R), Sterile, Spatula, Cervical, Cytology, Rovers Diagnostic Devices (1994). Our reading of the summary gave K942843, FDA’s number for Cervex-Brush (R), Sterile, Spatula, Cervical, Cytology (Rovers Diagnostic Devices). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips M1021A SvOz Module”. Kept off the family tree. Summary page 2.

## Most influential descendants
- 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
- K040259: Masimo Set Intellivue Pulse Oximeter Module (2004), 312 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. EASI 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 / tcpC02) is restricted to neonatal patients only. Bispectral Index (BIS) monitoring is for use in monitoring the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room, and for clinical research. The Bispectral Index, a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents*.

Source page: https://510kreport.com/device/K021778
Methodology: https://510kreport.com/methodology