510(k) · Cleared
ClearedDinamap Procare Series Monitor; Model 100, 200, 300, 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jul 2, 2002 as substantially equivalent to K992638 (Critikon Company, LLC, 2000) and 2 other predicates after a 188-day review. Its family tree reaches back 4 generations to 1997. 1 of the 42 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 188 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 19 ancestors in all, the oldest K896030 (1989). 22 later devices descend from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK992238 Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo…Masimo Corp. · 1999
- This deviceK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002
- Descendant · cites it directly · 21 of its ownK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
- Descendant · 2 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · 3 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · 3 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 4 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B405 generations on · 2014
Most influential descendants
Showing 5 of 22 · See all- K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002 · cites it directly21descendants
- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 2 generations on20descendants
- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 3 generations on11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 3 generations on10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT… | Masimo Corp. | 1999 | — |
| 0 (this device) | K014255 | Dinamap Procare Series Monitor; Model 100, 200, 300, 400 | Ge Medical Systems Information Technologies | 2002 | — |
| +1 | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002 | — |
| +2 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +3 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +3 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +4 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400Summary page 1…er Chart DSF 870.28 10 D. Predicate/Legally Marketed Devices DINAMAPB Pro Series Monitor 100-400-K992638 Critikon Company, LLC Welch Allyn Vital Signs Monitor-K95 1193 Welch Allyn Protocol/Tycos Industries Inc. E. Device… | 2000 |
| * | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1Summary page 1…870.28 10 D. Predicate/Legally Marketed Devices DINAMAPB Pro Series Monitor 100-400-K992638 Critikon Company, LLC Welch Allyn Vital Signs Monitor-K95 1193 Welch Allyn Protocol/Tycos Industries Inc. E. Device Description The DINAMAP ProCare Series Monitor is a prescription dev… | 1996 |
| * | K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci…Summary page 2…Series 100-400 K992638 sp02 I *Masirno SET Pulse Oximeter I K992238 Temperature I Alaris Medical System I K955846 I NI… | 1999 |
| Kept off the family tree | K955846 | FDA’s K955846 is Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount… Our reading of the summary gave K955846, FDA’s number for Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus… (Y). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alaris Medical System”. Kept off the family tree. Summary page 2…*Masirno SET Pulse Oximeter I K992238 Temperature I Alaris Medical System I K955846 I NIBP I *DINAMAP Pro Series 100-400 I K992638… | 1996 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | 2002 | 21 |
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 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K022193 (Ge Medical Systems Information Technologies, 2002) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K992638.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The DINAMAP@ProCare Series Monitor is intended to monitor a single adult, pediatric or
neonatal patient’s vital signs at the bedside or during intra-hospital transport. Vital signs
parameters include non-invasive blood pressure (systolic, diastolic, and mean
arterial pressure), pulse rate, andor oxygen saturation (pulse oximetry) andor temperature. The
portable device is designed for use in numerous clinical settings in various hospital departments
such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy,
cardiac step-down. It can also be used in satellite areas, physicians’ offices, or alternate care
settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014255 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014255: Dinamap Procare Series Monitor; Model 100, 200, 300, 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014255
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026