510(k) · Cleared
ClearedPress-Mate PM-2100 Vital Sign Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colin Medical Instruments Corp. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 13, 2002 as substantially equivalent to K890876 (Colin Medical Instruments Corp., 1989) and 3 other predicates after a 43-day review. Its family tree reaches back 2 generations to 1987. 50 later devices descend from it.
- Decided
- Sep 13, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K872291 (1987). 5 ancestors in all. 50 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 1 generation backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- This deviceK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- Descendant · cites it directly · 28 of its ownK071645 Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007
- Descendant · 2 generations on · 27 of its ownK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
- Descendant · 3 generations on · 24 of its ownK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 19 of its ownK130709 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K071645Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007 · cites it directly28descendants
- K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008 · 2 generations on27descendants
- K112478Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 3 generations on24descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 4 generations on20descendants
- K130709Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −1 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| 0 (this device) | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| +1 | K071645 | Model HBP T-105 Series, Model T-105 and T-105S | Omron Healthcare, Inc. | 2007 | — |
| +2 | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
| +3 | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +4 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +4 | K130709 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 MWI? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890876 | BP-8800 Blood Pressure MonitorSummary page 2…from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89) and the Press - Mate Advantage (K 973637 cleared 9/25/98) The following accessories are available for use wit… | 1989 |
| * | K921048 | BP8800T/8000IR/8300G Non-Invasive Blood Pres. SystSummary page 3…devices with respect to indications for use, device design, materials, and method of manufacture. Colin Corporation, Press-Mate 8800 Monitor (K890876; K921048C; K942871) Colin Corporation, Press-Mate Advantage Monitor (K973637) Substantial Equivalence Comparison:… | 1993 |
| * | K942871 | Press-Mate BP8800MS Automatic Non-Invasive Blood Pressure SystemSummary page 3…ith respect to indications for use, device design, materials, and method of manufacture. Colin Corporation, Press-Mate 8800 Monitor (K890876; K921048C; K942871) Colin Corporation, Press-Mate Advantage Monitor (K973637) Substantial Equivalence Comparison: The Press-… | 1994 |
| * | K973637 | Press-Mate AdvantageSummary page 2…able battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89) and the Press - Mate Advantage (K 973637 cleared 9/25/98) The following accessories are available for use with the device: 1. Power cord 2. Printer Paper 3. Operation… | 1998 |
What descends from it? (50)
See all 503 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 15 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K071645 (Omron Healthcare, Inc., 2007) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K890876.
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 Press-Mate PM-2100 patient monitor is intended to monitor a single patient’s vital signs in the hospital, outpatient surgery practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient’s medical condition. The patient populations include adult, pediatric and neonatal. The device is capable…
Read the full statement (103 words)
The Press-Mate PM-2100 patient monitor is intended to monitor a single patient’s vital signs in the
hospital, outpatient surgery practitioner facilities or in an environment where patient care is
provided by qualified healthcare personnel who will determine when use of this device is indicated,
based upon their professional assessment of the patient’s medical condition. The patient
populations include adult, pediatric and neonatal. The device is capable of monitoring”
Pulse rate (via oximetry data)
Non-invasive pressure (systolic, diastolic and mean oscillometric NIBP)
Temperature
Blood oxygen saturation (SPO, via finger oximeter)
This device is intended for use by qualified healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022537: Press-Mate PM-2100 Vital Sign Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022537
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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