510(k) · Cleared
ClearedNellcor Portable Pulse Oximeter Model N-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor, Inc. · DQA Oximeter
Cleared on May 27, 1993 after a 521-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.
- Decided
- May 27, 1993
- Review
- 521 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly.
- This deviceK915699 Nellcor Portable Pulse Oximeter Model N-20Nellcor, Inc. · 1993
- Descendant · cites it directly · 58 of its ownK963707 Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996
- Descendant · 2 generations on · 28 of its ownK051352 Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005
- Descendant · 3 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 15 of its ownK070193 Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH · 2007
- Descendant · 3 generations on · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K963707Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996 · cites it directly58descendants
- K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005 · 2 generations on28descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on19descendants
- K070193Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH · 2007 · 2 generations on15descendants
- K113165Mini-MedicAthena Gtx · 2012 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915699 | Nellcor Portable Pulse Oximeter Model N-20 | Nellcor, Inc. | 1993 | — |
| +1 | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40) | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +2 | K051352 | Oximax NPB-40 Handheld Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2005 | — |
| +3 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K070193 | Envitec Oxipen Pulse Oximeter and Accessories | Envitec-Wismar GmbH | 2007 | — |
| +3 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (60)
See all 602 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?
- Of its descendants, K963707 (Nellcor Puritan Bennett, Inc., 1996) has gone furthest, with 58 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/K915699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915699: Nellcor Portable Pulse Oximeter Model N-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915699
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026