510(k) · Cleared
ClearedNBM-200MP Pulse Oximetry Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orsense, Ltd. · DQA Oximeter
Cleared on Mar 19, 2010 as substantially equivalent to K053269 (Masimo Corporation, 2005) and 2 other predicates after a 295-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 19, 2010
- Review
- 295 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000126 (2000). 11 ancestors in all, the oldest K822055 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 3 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 2 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 1 generation backK053269 Masimo Set Rad-8 Pulse OximeterMasimo Corporation · 2005
- This deviceK091564 NBM-200MP Pulse Oximetry DeviceOrsense, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK124041 NBM-200MPOrsense, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK142209 Pulse oximeter NBM-200Orsense, Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −3 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −2 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −1 | K053269 | Masimo Set Rad-8 Pulse Oximeter | Masimo Corporation | 2005 | — |
| 0 (this device) | K091564 | NBM-200MP Pulse Oximetry Device | Orsense, Ltd. | 2010 | — |
| +1 | K124041 | NBM-200MP | Orsense, Ltd. | 2013 | — |
| +2 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K053269 | Masimo Set Rad-8 Pulse OximeterSummary page 2…OrSense 510O(k) -SET Rad-8 Pulse Oximeter (K053269) manufactured by Masimo corp. SET Rad-8 is a pulse oximeter device, similar to the NBM-… | 2005 |
| * | K910077 | Crit-ScanSummary page 2…corp. SET Rad-8 is a pulse oximeter device, similar to the NBM- 200MP pulse oximeter device. -CHIT-SCAN (K910077) manufactured by In-Line Diagnostics. CRIT-SCAN is a non-invasive hemnatocrit measuring device,… | 1992 |
| * | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Summary page 2…s also using a pnieumatic cuff technology for temporary inflation and deflation around a finger. -BMEYE NEXFLNHD (K072049) manufactured by BMEYE B.V. (The Netherlands). BMEYE NEXFIN_HD is a non-invasive mo… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124041 | NBM-200MP | 2013 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K124041 (Orsense, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K053269.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform. Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for…
Read the full statement (110 words)
The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform.
Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions.
It may be used on adult patients in the hospital or clinical environments.
The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.
The NBM-200MP is NOT intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091564: NBM-200MP Pulse Oximetry Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091564
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