510(k) · Cleared
ClearedOximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N
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 May 23, 2003 as substantially equivalent to K012891 (Nellcor Puritan Bennett, Inc., 2002) after a 59-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962603 (1997). 9 ancestors in all, the oldest K904039 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- This deviceK030930 Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK050583 Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2005
- Descendant · 2 generations on · 0 of its ownK072976 Model 250CX Series Maternal/Fetal MonitorGE Healthcare · 2007
- Descendant · cites it directly · 0 of its ownK041964 Mediaid Reusable Finger Clip SPO2 Sensors and Disposable…Mediaid, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK041644 Flexi-Stat Disposable Non-Adhesive SPO2 Sensors…Elekon Industries U.S.A., Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2005 · cites it directly1descendant
- K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare · 2007 · 2 generations on0descendants
- K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc. · 2004 · cites it directly0descendants
- K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| 0 (this device) | K030930 | Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N | Nellcor Puritan Bennett, Inc. | 2003 | — |
| +1 | K050583 | Model 250 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 2005 | — |
| +2 | K072976 | Model 250CX Series Maternal/Fetal Monitor | GE Healthcare | 2007 | — |
| +1 | K041964 | Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors… | Mediaid, Inc. | 2004 | — |
| +1 | K041644 | Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible)… | Elekon Industries U.S.A., Inc. | 2004 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 4…™ Sensors Oxygen Sensor Oximeter (DQA) per 21 CFR §870.2700 Nellcor Puritan Bennett, Inc., OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors, K012891 The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-achesive sensors. These sensors have a hook and loo… | 2002 |
What descends from it? (4)
3 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)
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 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K050583 (Ge Medical Systems Information Technologies, 2005) has gone furthest, with 1 descendant of its own.
- 33 other devices also cite its predicate K012891.
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 Nellcor OxiMax Softcare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg. The Nellcor OxiMax Softcare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less…
Read the full statement (135 words)
The Nellcor OxiMax Softcare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg.
The Nellcor OxiMax Softcare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg.
The Nellcor OxiMax Softcare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg.
The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-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.
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/K030930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030930: Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030930
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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