510(k) · Cleared
Recalled · 2004Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · DQA Oximeter
Cleared on Mar 7, 2002 as substantially equivalent to K991823 (Nellcor Puritan Bennett, Inc., 1999) and 3 other predicates after a 191-day review. Its family tree reaches back 4 generations to 1997. 2 of the 557 devices in its family, counting itself, have a Class I recall. 548 later devices descend from it. It has been recalled once.
- Decided
- Mar 7, 2002
- Review
- 191 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 8 ancestors in all, the oldest K904039 (1990). 548 later devices descend from it, 34 citing it directly. 2 of the 557 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- This deviceK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002
- Descendant · cites it directly · 426 of its ownK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- Descendant · 2 generations on · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- Descendant · cites it directly · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- Descendant · cites it directly · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- Descendant · cites it directly · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Showing 5 of 548 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 548 · See all- K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002 · cites it directly426descendants
- K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · 2 generations on290descendants
- K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · cites it directly272descendants
- K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · cites it directly264descendants
- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · cites it directly250descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | — |
| +1 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| +2 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| +1 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| +1 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| +1 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 21 | 0 |
| 2010 | 22 | 0 |
| 2011 | 20 | 0 |
| 2012 | 27 | 0 |
| 2013 | 28 | 0 |
| 2014 | 27 | 2 |
| 2015 | 35 | 0 |
| 2016 | 25 | 0 |
| 2017 | 27 | 0 |
| 2018 | 31 | 0 |
| 2019 | 27 | 0 |
| 2020 | 22 | 0 |
| 2021 | 22 | 0 |
| 2022 | 38 | 0 |
| 2023 | 33 | 0 |
| 2024 | 30 | 0 |
| 2025 | 31 | 0 |
| 2026 | 24 | 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.
2 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…CFR §870.2700) Patient Transducer and Electrode Cable (including connector) (74DSA) (per 21 CFR §870.2900) 1. Nellcor Puritan Bennett Inc. N-395 Pulse Oximeter, 510(k) #K991823 2. Nellcor Puritan Bennett Inc. N-395 Pulse Oximeter, With Extended Device Claims, 510(k) #K993637 3. Nellcor Inc. Reflectance… | 1999 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1….2900) 1. Nellcor Puritan Bennett Inc. N-395 Pulse Oximeter, 510(k) #K991823 2. Nellcor Puritan Bennett Inc. N-395 Pulse Oximeter, With Extended Device Claims, 510(k) #K993637 3. Nellcor Inc. Reflectance Sensor (RS-10), 510(k) #K904039 4. Nellcor N-20PA Portable Pulse Oximeter, 510(k) #K952222 The Oxi… | 1999 |
| * | K904039 | Reflectance Sensor (RS-10)Summary page 1…510(k) #K991823 2. Nellcor Puritan Bennett Inc. N-395 Pulse Oximeter, With Extended Device Claims, 510(k) #K993637 3. Nellcor Inc. Reflectance Sensor (RS-10), 510(k) #K904039 4. Nellcor N-20PA Portable Pulse Oximeter, 510(k) #K952222 The OxiMAX Pulse Oximetry System is designed for continuous, non-inv… | 1990 |
| * | K952222 | Nellcor N-20PA Portable Pulse OximeterSummary page 1…e Oximeter, With Extended Device Claims, 510(k) #K993637 3. Nellcor Inc. Reflectance Sensor (RS-10), 510(k) #K904039 4. Nellcor N-20PA Portable Pulse Oximeter, 510(k) #K952222 The OxiMAX Pulse Oximetry System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial… | 1995 |
What descends from it? (548)
See all 54834 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | 2002 | 426 |
| K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL… | 2004 | 272 |
| K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS… | 2005 | 264 |
| K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor | 2006 | 250 |
| K060576 | Nellcor Oximax N-600X Pulse Oximeter | 2006 | 140 |
| K073036 | Fore-Sight, MC-2000 Series | 2008 | 59 |
| K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | 2009 | 58 |
| K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring… | 2014 | 40 |
| K123581 | Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring… | 2013 | 34 |
| K022193 | Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N | 2002 | 21 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2004 | Not classified | Z-0664-05 | Other | The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency. |
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.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K021090 (Nellcor Puritan Bennett, Inc., 2002) has gone furthest, with 426 descendants of its own.
- 20 other devices also cite its predicate K991823.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The OxiMAX Pulse Oximetry System 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, hospital-type…
Read the full statement (772 words)
The OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The OxiMAX Pulse Oximetry System 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, hospital-type facilities, intra-hospital transport, and home environments. These devices are for prescription use only.
The Nellcor OxiMAX adult oxygen sensor, model MAX-A, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.
The Nellcor OxiMAX adult oxygen sensor, model MAX-AL, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.
The Nellcor OxiMAX pediatric oxygen sensor, model MAX-P, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
The Nellcor OxiMAX infant oxygen sensor, model MAX-I, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 and 20 kg.
The Nellcor OxiMAX neonatal/adult oxygen sensor, model MAX-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg or adults weighing more than 40 kg.
The Nellcor OxiMAX adult nasal oxygen sensor, model MAX-R, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 50 kg.
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg.
The Nellcor OxiMAX OxiCliq adult oxygen sensor, model A, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The OxiClig-A sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3.
The Nellcor OxiMAX OxiCliq pediatric oxygen sensor, model P, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg. The OxiCliq-P sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3.
The Nellcor OxiMAX OxiCliq infant oxygen sensor, model I, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 and 20 kg. The OxiClig-I sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3.
The Nellcor OxiMAX OxiCliq neonatal/adult oxygen sensor, model N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg, or adults weighing more than 40 kg. The OxiClig-N sensor is for use only with a Nellcor OxiCliq sensor cable, model OC-3.
The Nellcor OxiMAX Durasensor adult oxygen sensor, model DS-100A, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg.
The Nellcor OxiMAX Dura-Y multisite oxygen sensor, model D-YS, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 1 kg.
The Nellcor Dura-Y ear clip, model D-YSE, is intended for use only with the Nellcor OxiMAX Dura-Y oxygen sensor, model D-YS, when continuous, noninvasive arterial oxygen saturation and pulse rate monitoring are required. It is indicated for use for patients weighing 30 kg or more, using the ear lobe or pinna as a monitoring site.
The Nellcor PediCheck pediatric spot-check clip, model D-YSPD, is intended for use only with the Nellcor OxiMAX Dura-Y oxygen sensor, model D-YS, when noninvasive, arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 kg and 40 kg.
The Nellcor OxiMAX Oxiband pediatric/infant oxygen sensor, model OXI-P/I, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 3 kg and 40 kg.
The Nellcor OxiMAX Oxiband adult/neonatal oxygen sensor, model OXI-A/N, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg.
The Nellcor pulse oximetry cable, model DOC-10, is a 10-foot (3-meter) cable that links a Nellcor oxygen sensor to a compatible Nellcor pulse oximeter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012891
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026