510(k) · Cleared
ClearedBionet BM3PLUS Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Dec 11, 2008 as substantially equivalent to K021154 (Goldway Us, Inc., 2003) after a 149-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Dec 11, 2008
- Review
- 149 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021154 (2003). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K132033BM3/BM3 PlusNoblitt & Rueland · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021154 | Goldway Patient Monitor, Model # UT4000F | Goldway Us, Inc. | 2003 | — |
| 0 (this device) | K082008 | Bionet BM3PLUS Patient Monitor | Bionet Co., Ltd. | 2008 | — |
| +1 | K132033 | BM3/BM3 Plus | Noblitt & Rueland | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K021154 | Goldway Patient Monitor, Model # UT4000FSummary page 1…Common Name: Multifunctional patient monitor Classification Name: Monitor, Physiological, Patient 3. Predicate Device: Goldway UT4000F Patient Monitor (K021154) 4. Device Description: Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132033 | BM3/BM3 Plus | 2013 | 0 |
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 MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities. Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature…
Read the full statement (130 words)
The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.
Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082008 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082008: Bionet BM3PLUS Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082008
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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