510(k) · Cleared
ClearedBeside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Sep 28, 2012 as substantially equivalent to K083325 (Covidien, 2009) and 1 other predicate after a 100-day review. Its family tree reaches back 10 generations to 1997. 1 of the 94 devices in its family, counting itself, has a Class I recall. 45 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962603 (1997). 48 ancestors in all, the oldest K863784 (1986). 45 later devices descend from it, 3 citing it directly. 1 of the 94 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations between
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK051896 Model 750E Series MonitorCas Medical Systems, Inc. · 2005
- 1 generation backK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- This deviceK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
- Descendant · cites it directly · 40 of its ownK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- Descendant · cites it directly · 29 of its ownK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015
- Descendant · 2 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- Descendant · 3 generations on · 10 of its ownK181352 Loop SystemSpry Health, Inc. · 2019
- Descendant · 4 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
Show all 10 generations
- Root · 10 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 8 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 7 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 6 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 5 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 4 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 2 generations backK051896 Model 750E Series MonitorCas Medical Systems, Inc. · 2005
- 1 generation backK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- This deviceK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus5 generations back · 1997
Most influential descendants
Showing 5 of 45 · See all- K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien · 2014 · cites it directly40descendants
- K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015 · cites it directly29descendants
- K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 2 generations on23descendants
- K181352Loop SystemSpry Health, Inc. · 2019 · 3 generations on10descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −9 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −8 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −7 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −6 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −5 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −4 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −3 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −2 | K051896 | Model 750E Series Monitor | Cas Medical Systems, Inc. | 2005 | — |
| −1 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| 0 (this device) | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
| +1 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient… | Covidien | 2014 | — |
| +1 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015 | — |
| +2 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| +3 | K181352 | Loop System | Spry Health, Inc. | 2019 | — |
| +4 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 1 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K083325 | N-600X with SPD, Oximax N-600XSummary page 1…distribution: Trade Name: N-600x Pulse Oximeter with Oximax SPID Alert Device Common Name: Oximeter 510(k) Number: K083325 (cleared 3/2009) Manufacturer: Covidien, formerly Nellcor, a division of Tyco Healthcare Trade Name:… | 2009 |
| * | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0Summary page 1…ealthcare Trade Name: Covidien Respiration Rate Software Device Common Name: Monitor, breathing frequency 510(k) Number: K1 11933 (cleared 3/201 2) Manufacturer: Covidien, formerly Nelleor, a division of Tyco Healthcare 510(k) - Covidien… | 2012 |
| † | K060576 | Nellcor Oximax N-600X Pulse Oximeter | 2006 |
What descends from it? (45)
See all 453 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 11 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 11 months on median.
- 7 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130320 (Covidien, 2014) has gone furthest, with 40 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?
For Covidien Nelicor Bedside Respiratory Patient Monitoring System with Respiration Rate Software: The Nellcor h Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO 2) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in…
Read the full statement (149 words)
For Covidien Nelicor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:
The Nellcor h Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO 2) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD Tm Alert (SPO) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Neilcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121806
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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