510(k) · Cleared
ClearedDinamap MPS Portable Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 19, 1997 as substantially equivalent to K955113 (Johnson & Johnson Medical, Inc., 1996) after a 143-day review. Its family tree reaches back 2 generations to 1989. 1 of the 54 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 143 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896030 (1989). 10 ancestors in all. 43 later devices descend from it, 3 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK896030 Hewlett-Packard Model M1016A CO2 & M1017A FI02Hewlett-Packard Co. · 1989
- 1 generation backK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
- This deviceK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
- Descendant · cites it directly · 40 of its ownK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
- Descendant · 2 generations on · 22 of its ownK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002
- Descendant · 3 generations on · 21 of its ownK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
- Descendant · 4 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · 2 generations on · 13 of its ownK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B407 generations on · 2014
Most influential descendants
Showing 5 of 43 · See all- K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000 · cites it directly40descendants
- K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002 · 2 generations on22descendants
- K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002 · 3 generations on21descendants
- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 4 generations on20descendants
- K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896030 | Hewlett-Packard Model M1016A CO2 & M1017A FI02 | Hewlett-Packard Co. | 1989 | — |
| −1 | K955113 | Dinamap Select Multi-Parameter System | Johnson & Johnson Medical, Inc. | 1996 | — |
| 0 (this device) | K971569 | Dinamap MPS Portable Monitor | Johnson & Johnson Medical, Inc. | 1997 | — |
| +1 | K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400 | Critikon Company, LLC | 2000 | — |
| +2 | K014255 | Dinamap Procare Series Monitor; Model 100, 200, 300, 400 | Ge Medical Systems Information Technologies | 2002 | — |
| +3 | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002 | — |
| +4 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +2 | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K955113 | Dinamap Select Multi-Parameter SystemSummary page 2…onitor is substantially equivalent to the currently-marketed DINAMAP MPS Select Monitor (“Select Monitor”) which received marketing clearance August 15, 1996, via 510(k) K955113. The DINAMAP MPS Portable Monitor is a prescription device intended for use only by health care professionals. It can be used in… | 1996 |
What descends from it? (43)
See all 433 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K992638 (Critikon Company, LLC, 2000) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K955113.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The DINAMAP MPS* Select* Portable Monitor is intended to monitor a single patient’s vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device (K955113) and include connection to the OBSERVER* Central Station via VHF, spread spectrum or hardwire communication; host communications…
Read the full statement (129 words)
The DINAMAP MPS* Select* Portable Monitor is intended to monitor a single patient’s vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device (K955113) and include connection to the OBSERVER* Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP* Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NiMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971569: Dinamap MPS Portable Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971569
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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