510(k) · Cleared
ClearedGE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · DQA Oximeter
Cleared on Jul 20, 2020 as substantially equivalent to K172482 (Covidien, 2017) after an 80-day review. Its family tree reaches back 14 generations to 1997. 1 of the 54 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 20, 2020
- Review
- 80 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962603 (1997). 53 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- 2 generations backK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015
- 1 generation backK172482 The Nellcor pulse oximetry monitor interface cableCovidien · 2017
- This deviceK201179 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC · 2020
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 9 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 8 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 6 generations backK051896 Model 750E Series MonitorCas Medical Systems, Inc. · 2005
- 5 generations backK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
- 4 generations backK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
- 3 generations backK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
- 2 generations backK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015
- 1 generation backK172482 The Nellcor pulse oximetry monitor interface cableCovidien · 2017
- This deviceK201179 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC · 2020
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −9 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −8 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −7 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K051896 | Model 750E Series Monitor | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
| −4 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient… | Covidien | 2012 | — |
| −3 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient… | Covidien | 2014 | — |
| −2 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015 | — |
| −1 | K172482 | The Nellcor pulse oximetry monitor interface cable | Covidien | 2017 | — |
| 0 (this device) | K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Covidien, LLC | 2020 | — |
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 |
| 2013 | 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.
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? (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 |
|---|---|---|---|
| * | K172482 | The Nellcor pulse oximetry monitor interface cableSummary page 5…Covidien, llc Device Name: The Nellcor Pulse Oximetry Monitor Interface Cable 510(k) number: K172482 Clearance Date: 12/15/2017 Subject Device Description The subject device of this premarket 510(k… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 53 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 GE ApexPro CH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities. • Note: Hospital use typically…
Read the full statement (210 words)
The GE ApexPro CH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check
or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during
both no motion and motion conditions and for patients who are either well or poorly perfused, in
hospitals and hospital-type facilities.
• Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric
Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general
care floor (GCF).
• Note: Hospital-type facilities include step-down units and long-term care facilities.
The GE ApexPro FH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check
or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during
both no motion and motion conditions and for patients who are either well or poorly perfused, in
hospitals and hospital-type facilities.
• Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric
Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general
care floor (GCF).
• Note: Hospital-type facilities include step-down units and long-term care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201179: GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201179
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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