510(k) · Cleared
ClearedCarescape V100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 29, 2007 as substantially equivalent to K022193 (Ge Medical Systems Information Technologies, 2002) and 2 other predicates after a 16-day review. Its family tree reaches back 6 generations to 1997. 3 of the 59 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962603 (1997). 38 ancestors in all, the oldest K896030 (1989). 20 later devices descend from it, 2 citing it directly. 3 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
- This deviceK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
- Descendant · cites it directly · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
- Descendant · cites it directly · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · cites it directly11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · cites it directly10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 2 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on7descendants
- K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002 | — |
| 0 (this device) | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | — |
| +1 | K102426 | Carescape Model V100 Vital Signs Monitor | Ge Medical Systems Information Technologies | 2010 | — |
| +1 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +2 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +3 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| +4 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 1 |
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NSummary page 1…hermometer, Clinical Electronic Recorder, Paper Chart Predicate Devices: DINAMAP® ProCare Series 10ON-A0ON Monitor (K022193) DINAMAP® Pro 1000 Monitor with SuperSTAT (K022834) Datex-Ohmeda TruSat Pulse… | 2002 |
| * | K022834 | Dinamap Pro 1000 Monitor with Superstat, Model 1000Summary page 1…t Predicate Devices: DINAMAP® ProCare Series 10ON-A0ON Monitor (K022193) DINAMAP® Pro 1000 Monitor with SuperSTAT (K022834) Datex-Ohmeda TruSat Pulse Oximeter and Accessories (K040831) Device Description:… | 2003 |
| * | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Summary page 1…nitor (K022193) DINAMAP® Pro 1000 Monitor with SuperSTAT (K022834) Datex-Ohmeda TruSat Pulse Oximeter and Accessories (K040831) Device Description: The CARESCAPE V100 Vital Signs Monitor is a small, portable monitor… | 2004 |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 13 Class I recalls
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 10 of the 38 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K102426 (Ge Medical Systems Information Technologies, 2010) has gone furthest, with 11 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The CARESCAPE V100 Vital Signs 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, and/or oxygen saturation (pulse oximetry) and/or 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. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073203: Carescape V100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073203
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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