510(k) · Cleared
ClearedNellcor N-200 (Pulse Oximeter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor, Inc. · DQA Oximeter
Cleared on Nov 21, 1986 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 274 devices in its family, counting itself, have a Class I recall. 273 later devices descend from it.
- Decided
- Nov 21, 1986
- Review
- 56 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
273 later devices descend from it, 14 citing it directly. 3 of the 274 devices in this family, counting this one, have a Class I recall.
- This deviceK863784 Nellcor N-200 (Pulse Oximeter)Nellcor, Inc. · 1986
- Descendant · cites it directly · 141 of its ownK022819 Nellcor N-200 Pulse Oximeter, Model N-200Nellcor Puritan Bennett, Inc. · 2002
- Descendant · cites it directly · 140 of its ownK060576 Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
- Descendant · cites it directly · 95 of its ownK033298 SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp. · 2003
- Descendant · 2 generations on · 86 of its ownK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- Descendant · cites it directly · 85 of its ownK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 273 · See all- K022819Nellcor N-200 Pulse Oximeter, Model N-200Nellcor Puritan Bennett, Inc. · 2002 · cites it directly141descendants
- K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006 · cites it directly140descendants
- K033298SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp. · 2003 · cites it directly95descendants
- K041815LNCS Oximetry SensorsMasimo Corp. · 2004 · 2 generations on86descendants
- K051212Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · cites it directly85descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863784 | Nellcor N-200 (Pulse Oximeter) | Nellcor, Inc. | 1986 | — |
| +1 | K022819 | Nellcor N-200 Pulse Oximeter, Model N-200 | Nellcor Puritan Bennett, Inc. | 2002 | — |
| +1 | K060576 | Nellcor Oximax N-600X Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2006 | — |
| +1 | K033298 | SPO2.Com Oximetry Sensors, Multiple Models | Masimo Corp. | 2003 | — |
| +2 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| +1 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 1 |
| 2008 | 4 | 0 |
| 2009 | 10 | 1 |
| 2010 | 10 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 1 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 7 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 10 | 0 |
| 2022 | 22 | 0 |
| 2023 | 18 | 0 |
| 2024 | 18 | 0 |
| 2025 | 25 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (273)
See all 27314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022819 | Nellcor N-200 Pulse Oximeter, Model N-200 | 2002 | 141 |
| K060576 | Nellcor Oximax N-600X Pulse Oximeter | 2006 | 140 |
| K033298 | SPO2.Com Oximetry Sensors, Multiple Models | 2003 | 95 |
| K051212 | Modification to LNCS Oximetry Sensors | 2005 | 85 |
| K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos) | 1996 | 67 |
| K030952 | Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313… | 2003 | 3 |
| K041867 | Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N | 2004 | 2 |
| K033349 | AC-1 SP02 Adaptor Cable, Model AC-1 | 2004 | 2 |
| K012677 | Reprocessed Pulse Oximeter Sensors | 2003 | 1 |
| K971946 | NPB-190 Pulse Oximeter (NPB-190) | 1997 | 1 |
Has anything in its family been recalled? (3 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.
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022819 (Nellcor Puritan Bennett, Inc., 2002) has gone furthest, with 141 descendants of its own.
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 | — |
https://510kreport.com/device/K863784 · printed Nov 4, 2026
Cite this page
510(k) Report. “K863784: Nellcor N-200 (Pulse Oximeter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863784
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026