510(k) · Cleared
ClearedDinamap MPS Select Portable Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critikon Company, LLC · MSX System, Network And Communication, Physiological Monitors
Cleared on Aug 14, 1998 as substantially equivalent to K971569 (Johnson & Johnson Medical, Inc., 1997) after a 39-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Aug 14, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896030 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK896030 Hewlett-Packard Model M1016A CO2 & M1017A FI02Hewlett-Packard Co. · 1989
- 2 generations backK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
- 1 generation backK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
- This deviceK982342 Dinamap MPS Select Portable MonitorCritikon Company, LLC · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896030 | Hewlett-Packard Model M1016A CO2 & M1017A FI02 | Hewlett-Packard Co. | 1989 | — |
| −2 | K955113 | Dinamap Select Multi-Parameter System | Johnson & Johnson Medical, Inc. | 1996 | — |
| −1 | K971569 | Dinamap MPS Portable Monitor | Johnson & Johnson Medical, Inc. | 1997 | — |
| 0 (this device) | K982342 | Dinamap MPS Select Portable Monitor | Critikon Company, LLC | 1998 | — |
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 |
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 MSX? 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 |
|---|---|---|---|
| * | K971569 | Dinamap MPS Portable MonitorSummary page 2…le Monitor is substantially equivalent to the currently-marketed DINAMAP MPS® Select® Portable Monitor which received marketing clearance September 19, 1997, via 510(k) K971569. The modified DINAMAP MPS® Select® Portable Monitor device description is identical to the currently-marketed device. The differ… | 1997 |
| † | K955113 | Dinamap Select Multi-Parameter System | 1996 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K971569.
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 and include connection to the OBSERVER® Central Station via VHF, spread spectrum or hardwire communication; host communications for use on…
Read the full statement (128 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 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/K982342 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982342: Dinamap MPS Select 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/K982342
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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