510(k) · Cleared
ClearedPulse Oximeter (MD300M/MD300K2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technology Co., Ltd. · DQA Oximeter
Cleared on Apr 18, 2016 as substantially equivalent to K090599 (Beijing Choice Electronic Technololgy Co., Ltd., 2009) after a 222-day review. Its family tree reaches back 15 generations to 1994. 8 later devices descend from it.
- Decided
- Apr 18, 2016
- Review
- 222 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K941811 (1994). 104 ancestors in all, the oldest K842616 (1984). 8 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations between
- 3 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 1 generation backK090599 MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- This deviceK152563 Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 3 generations on · 1 of its ownK233292 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2023
- Descendant · 3 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK263010 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…inomed Medizintechnik GmbH · 2026
Show all 15 generations
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 13 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 12 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 11 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 10 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 9 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 8 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 7 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 6 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 5 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 2 generations backK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 1 generation backK090599 MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- This deviceK152563 Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · cites it directly7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 2 generations on5descendants
- K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2023 · 3 generations on1descendant
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 3 generations on1descendant
- K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −14 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −13 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −12 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −11 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −10 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −9 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −8 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −7 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −6 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −5 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −2 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −1 | K090599 | MD300K1 Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| 0 (this device) | K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016 | — |
| +1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +2 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +3 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | — |
| +3 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
| +2 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K090599 | MD300K1 Pulse OximeterSummary page 4…r Model: MD300M, MD300K2 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: Ⅱ Panel: Anesthesiology 3.3 Predicate Device 510(k) Number: K090599 III-1 Premarket Notification 510(k) Submission—Section III 510(k) Summar… | 2009 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162199 | Cascade IOMAX Intraoperative Monitor | 2017 | 7 |
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 22 years and passes through 8 companies; a new generation was cleared every 5 months on median.
- 13 of the 104 ancestors have a recall of any class.
- Of its descendants, K162199 (Cadwell Industries, Inc., 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2)
and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152563: Pulse Oximeter (MD300M/MD300K2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152563
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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