510(k) · Cleared
ClearedMcare 300 Vital Signs Monitor, Model 91220
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Sep 29, 2006 as substantially equivalent to K013046 (Spacelabs Medical, Inc., 2002) and 3 other predicates after a 67-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K962603 (1997). 26 ancestors in all, the oldest K904039 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 2 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 1 generation backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- This deviceK062095 Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK100217 Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK112190 Patient MonitorMediana Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK082045 Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2008 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd. · 2010 · cites it directly1descendant
- K112190Patient MonitorMediana Co., Ltd. · 2011 · cites it directly0descendants
- K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −2 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −1 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| 0 (this device) | K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2006 | — |
| +1 | K100217 | Lucon M-Series Patient Monitor, Models M20 and M30 | Mediana Co., Ltd. | 2010 | — |
| +1 | K112190 | Patient Monitor | Mediana Co., Ltd. | 2011 | — |
| +1 | K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220 | Spacelabs Medical, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 MHX? 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? (5)
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 |
|---|---|---|---|
| * | K013046 | Cosmos SystemSummary page 2…ally Discussion: equivalent in design concepts, technologies and materials the Spacelabs Medical COSMOS SYSTEM, model 95000, patient monitor (K013046) with respect to ECG, respiration, IBP and arrhythmia processing; to the Welch-Allyn MS53… | 2002 |
| * | K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesSummary page 2…del 95000, patient monitor (K013046) with respect to ECG, respiration, IBP and arrhythmia processing; to the Welch-Allyn MS53000 (K031740) with respect to NIBP, the to Nellcor N-595 (KO12740) with respect to SpO2 and to the Respironics Capnostat 5… | 2003 |
| Kept off the family tree | K012740 | FDA’s K012740 is Clearfil AP-X Our reading of the summary gave K012740, FDA’s number for Clearfil AP-X (Kuraray Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Nellcor N-595”. Kept off the family tree. | 2001 |
| * | K042601 | Capnostat 5Summary page 2…Welch-Allyn MS53000 (K031740) with respect to NIBP, the to Nellcor N-595 (KO12740) with respect to SpO2 and to the Respironics Capnostat 5 (042601) and Lo Flo C5 (K053174) with respect to EtCO2. The mCARE 3000 Vital Signs Monitor suc… | 2004 |
| * | K053174 | Loflo C5 CO2 SensorSummary page 2…h respect to NIBP, the to Nellcor N-595 (KO12740) with respect to SpO2 and to the Respironics Capnostat 5 (042601) and Lo Flo C5 (K053174) with respect to EtCO2. The mCARE 3000 Vital Signs Monitor successfully underwent testing to… | 2006 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 companies; a new generation was cleared every 11 months on median.
- 12 of the 26 ancestors have a recall of any class.
- Of its descendants, K100217 (Mediana Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K013046.
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.
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 Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire COD.
The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062095: Mcare 300 Vital Signs Monitor, Model 91220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062095
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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