510(k) · Cleared
ClearedPhilips CS770 IntelliSpace Critical Care and Anesthesia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Oct 30, 2015 as substantially equivalent to K100272 (Philips Medical Systems, 2010) after a 162-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 30, 2015
- Review
- 162 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941811 (1994). 16 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 2 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 1 generation backK100272 Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · Recalled
- This deviceK151366 Philips CS770 IntelliSpace Critical Care and AnesthesiaPhilips Medical Systems · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −5 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −4 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −3 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −2 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −1 | K100272 | Intellivue Clinical Information Portfolio | Philips Medical Systems | 2010 | 2 |
| 0 (this device) | K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100272 | Intellivue Clinical Information PortfolioSummary page 6…re (Release H.0), a modified version of the IntelliVue Clinical Information Portfolio which was last cleared under premarket notification number K100272. ICCA is a software only product used for charting and data management, offers clinical decision and clinical workflow suppor… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 4 other devices also cite its predicate K100272.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The device is indicated for use whenever there is a need for generation of a patient record and computation of drug dosage in all areas patient care is given in the hospital, including critical care and anesthesia areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151366: Philips CS770 IntelliSpace Critical Care and Anesthesia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026