510(k) · Cleared
ClearedOxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Medical Technologies Co., Ltd. · DQA Oximeter
Cleared on Nov 16, 2009 as substantially equivalent to K993637 (Nellcor Puritan Bennett, Inc., 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 10 generations to 1994. 1 later device descends from it.
- Decided
- Nov 16, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941811 (1994). 48 ancestors in all, the oldest K872781 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 2 generations backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- 1 generation backK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
- This deviceK092549 Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK132516 Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd. · 2014
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 5 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 4 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 3 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 2 generations backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- 1 generation backK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
- This deviceK092549 Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −5 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −4 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| −3 | K030973 | Picosat II SPO2 Pulse Oximetry Module | Philips Medical Systems | 2003 | — |
| −2 | K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196T | Philips Medical Systems | 2006 | — |
| −1 | K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T… | Philips Medical Systems, Inc. | 2007 | — |
| 0 (this device) | K092549 | Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P | Bio Medical Technologies Co., Ltd. | 2009 | — |
| +1 | K132516 | Oxiprobe E (Oxiprobe) | Bio Medical Technologies Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1…Ox iprobE Common Name - Oximetry Sensor Classification Name - Oximeter 3. Predicate Device: Model D-25, N-25. D-20, Nellcor Puritan Bennett Inc.. K993637 Philips Reusable SpO2 Sensors-Mi 191T, MlI 192T. Philips Medical Systems, K063783 4. Classifications Names & Citations:… | 1999 |
| * | K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Summary page 1…3. Predicate Device: Model D-25, N-25. D-20, Nellcor Puritan Bennett Inc.. K993637 Philips Reusable SpO2 Sensors-Mi 191T, MlI 192T. Philips Medical Systems, K063783 4. Classifications Names & Citations: Regulation Number:. 21 CFR 870.2700 Regulation Name: Oximeter… | 2007 |
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 |
|---|---|---|---|
| K132516 | Oxiprobe E (Oxiprobe) | 2014 | 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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 48 ancestors have a recall of any class.
- Of its descendants, K132516 (Bio Medical Technologies Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K993637.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for jirescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092549: Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092549
Report an extraction error
Are you the manufacturer?
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