510(k) · Cleared
Recalled · Class II · 2025Nellcor Bedside SPO2 Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · DQA Oximeter
Cleared on Jul 10, 2012 as substantially equivalent to K083325 (Covidien, 2009) after a 118-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 22 ancestors in all, the oldest K863784 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 2 generations backK060576 Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
- 1 generation backK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- This deviceK120773 Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC · 2012
- Descendant · cites it directly · 3 of its ownK142865 Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK152659 V10Mediana Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK170497 V10Mediana Co., Ltd. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK131085 Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC · 2015 · cites it directly3descendants
- K152659V10Mediana Co., Ltd. · 2016 · 2 generations on2descendants
- K170497V10Mediana Co., Ltd. · 2017 · 3 generations on1descendant
- K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc. · 2013 · cites it directly1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −2 | K060576 | Nellcor Oximax N-600X Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2006 | — |
| −1 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| 0 (this device) | K120773 | Nellcor Bedside SPO2 Patient Monitoring System | Covidien, LLC | 2012 | — |
| +1 | K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | 2015 | 1 |
| +2 | K152659 | V10 | Mediana Co., Ltd. | 2016 | — |
| +3 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 |
| +1 | K131085 | Central Venous Pressure System - Mespere Venus 1000 | Mespere Lifesciences, Inc. | 2013 | — |
| +4 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K083325 | N-600X with SPD, Oximax N-600XSummary page 1…Nellcor" Bedside SP02 Patient Monitoring System is: Covidien Oximeter, Model Nelicor OxiMax N-600x Pulse Oximeter with SPID cleared by FDA through 510O(k) No. K083325 Device Description The Nellcorm Bedside SP0 2 Patient Monitoring System provides continuous, noninvasive monitoring of functiona… | 2009 |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2025 | Class II | Z-2151-2025 | Labeling design | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't… |
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 2.5 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K142865 (Covidien, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K083325.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Nellcor™ Bedside SpO₂ Patient Monitoring System is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The Nellcor™ Bedside SpO₂ Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport. Note: * Hospital…
Read the full statement (120 words)
The Nellcor™ Bedside SpO₂ Patient Monitoring System is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The Nellcor™ Bedside SpO₂ Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.
Note:
* Hospital use typically covers such areas as general care floors (GCFs), operating rooms, special procedure areas, intensive and critical care areas within the hospital, and in hospital-type facilities.
* Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.
* Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120773 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120773: Nellcor Bedside SPO2 Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120773
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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