510(k) · Cleared
ClearedPress-Mate Advantage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colin Medical Instruments Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 25, 1998 as substantially equivalent to K921048 (Colin Medical Instruments Corp., 1993) and 1 other predicate after a 366-day review. Its family tree reaches back 1 generation to 1987. 101 later devices descend from it.
- Decided
- Sep 25, 1998
- Review
- 366 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872291 (1987). 2 ancestors in all. 101 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- This deviceK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- Descendant · cites it directly · 50 of its ownK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- Descendant · cites it directly · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
- Descendant · 2 generations on · 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 ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- Descendant · cites it directly · 27 of its ownK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K022537Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002 · cites it directly50descendants
- K013434VP-2000/1000Colin Corp. · 2002 · cites it directly46descendants
- K071645Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007 · 2 generations on28descendants
- K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 2 generations on27descendants
- K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| 0 (this device) | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| +1 | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| +1 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| +2 | K071645 | Model HBP T-105 Series, Model T-105 and T-105S | Omron Healthcare, Inc. | 2007 | — |
| +2 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| +1 | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K921048 | BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst Our OCR of the scanned summary read K951048, FDA’s number for Rite-Bite Biopsy Forceps (Mill-Rose Laboratory). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PressMate Model 8800 Non-Invasive Blood Pressure Monitor”. | 1993 |
| * | K872291 | Escort Portable Patient MonitorSummary page 1…is being claimed are: PressMate Model 8800 Non-Invasive Blood Pressure Monitor K# (K951048) Manufactured by Colin Medical Instruments Corporation Escort Model 102 K# (K872291) Portable Vital Signs Monior Manufactured by: Medical Data Electronics Incorporated & 6. Device Description The… | 1987 |
What descends from it? (101)
See all 1015 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?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Ratc and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.
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/K973637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973637: Press-Mate Advantage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973637
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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