510(k) · Cleared
ClearedDinamap Pro Series Monitor, Models 100, 200, 300, 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critikon Company, LLC · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 24, 2000 as substantially equivalent to K955113 (Johnson & Johnson Medical, Inc., 1996) and 2 other predicates after a 202-day review. Its family tree reaches back 3 generations to 1989. 1 of the 54 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it.
- Decided
- Feb 24, 2000
- Review
- 202 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K896030 (1989). 13 ancestors in all. 40 later devices descend from it, 4 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- 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 deviceK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
- Descendant · cites it directly · 22 of its ownK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002
- Descendant · 2 generations on · 21 of its ownK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
- Descendant · 3 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · cites it directly · 13 of its ownK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 4 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B406 generations on · 2014
Most influential descendants
Showing 5 of 40 · See all- K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002 · cites it directly22descendants
- K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002 · 2 generations on21descendants
- K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 3 generations on20descendants
- K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly13descendants
- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 4 generations on11descendants
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) | K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400 | Critikon Company, LLC | 2000 | — |
| +1 | K014255 | Dinamap Procare Series Monitor; Model 100, 200, 300, 400 | Ge Medical Systems Information Technologies | 2002 | — |
| +2 | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002 | — |
| +3 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +1 | K063055 | VS-800 Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +4 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
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 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 1…an internal lead-acid rechargeable battery. The device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182… | 1996 |
| * | K971569 | Dinamap MPS Portable MonitorSummary page 1…technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97). Critikon Company LLC e 4110 George Road ¢ Tampa, F… | 1997 |
| * | K970182 | Dinamap Compact MonitorSummary page 1…MAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97). Critikon Company LLC e 4110 George Road ¢ Tampa, Florida 33634 « Telephone 813-237-2033 CRILLE… | 1997 |
What descends from it? (40)
See all 404 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 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K014255 (Ge Medical Systems Information Technologies, 2002) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K955113.
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® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient’s vital signs. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992638: Dinamap Pro Series Monitor, Models 100, 200, 300, 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992638
Report an extraction error
Are you the manufacturer?
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