510(k) · Cleared
ClearedPress-Mate BX-10 Vital Sign Monitor
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 Feb 4, 2004 as substantially equivalent to K890876 (Colin Medical Instruments Corp., 1989) and 4 other predicates after a 145-day review. Its family tree reaches back 3 generations to 1987. 19 later devices descend from it.
- Decided
- Feb 4, 2004
- Review
- 145 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K872291 (1987). 6 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 2 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 1 generation backK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- This deviceK032857 Press-Mate BX-10 Vital Sign MonitorColin Medical Instruments Corp. · 2004
- Descendant · cites it directly · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 6 of its ownK192514 Patient MonitorEdan Instruments, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 3 of its ownK202336 Patient MonitorEdan Instruments, Inc. · 2021 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K113623Patient MonitorEdan Instruments, Inc. · 2012 · cites it directly15descendants
- K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · 2 generations on14descendants
- K160981Patient MonitorEdan Instruments, Inc. · 2016 · 3 generations on8descendants
- K192514Patient MonitorEdan Instruments, Inc. · 2020 · 4 generations on6descendants
- K202336Patient MonitorEdan Instruments, Inc. · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −2 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −1 | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| 0 (this device) | K032857 | Press-Mate BX-10 Vital Sign Monitor | Colin Medical Instruments Corp. | 2004 | — |
| +1 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +2 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 2 |
| +3 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 1 |
| +4 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 1 |
| +5 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 1 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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? (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.
| 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),Press - Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02) The fo… | 1989 |
| * | K921048 | BP8800T/8000IR/8300G Non-Invasive Blood Pres. SystSummary page 3…cated 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) Colin Medical Instruments, Press-Mate Prodigy(PM-2100… | 1993 |
| * | K942871 | Press-Mate BP8800MS Automatic Non-Invasive Blood Pressure SystemSummary page 3…ces 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) Colin Medical Instruments, Press-Mate Prodigy(PM-2100) (K022537… | 1994 |
| * | K973637 | Press-Mate AdvantageSummary page 2…rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89),Press - Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02) The following accessories are available for use with the… | 1998 |
| * | K022537 | Press-Mate PM-2100 Vital Sign MonitorSummary page 2…ogy and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89),Press - Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02) The following accessories are available for use with the device: 1. Power cord 2. Printer Paper 3. Operation… | 2002 |
What descends from it? (19)
See all 193 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 17 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K113623 (Edan Instruments, Inc., 2012) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K890876.
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 Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional 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 Press-Mate BX-10 patient…
Read the full statement (108 words)
The Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional 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 Press-Mate BX-10 patient monitor is intended to monitor a single patient's non-invasive blood pressure and pulse rate.
The Press-Mate BX-1OAn patient monitor is intended to monitor a single patient's non-invasive blood pressure as well as blood oxygen saturation and pulse rate via Nellcor's oximetry technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032857 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032857: Press-Mate BX-10 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/K032857
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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