510(k) · Cleared
ClearedNellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · DPS Electrocardiograph
Cleared on Jul 2, 1996 after a 203-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 of the 818 devices in its family, counting itself, have a Class I recall. 817 later devices descend from it.
- Decided
- Jul 2, 1996
- Review
- 203 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
817 later devices descend from it, 3 citing it directly. 6 of the 818 devices in this family, counting this one, have a Class I recall.
- This deviceK955642 Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200…Nellcor Puritan Bennett, Inc. · 1996
- Descendant · cites it directly · 785 of its ownK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- Descendant · cites it directly · 715 of its ownK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 548 of its ownK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 426 of its ownK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- Descendant · 4 generations on · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
Showing 5 of 817 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 817 · See all- K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999 · cites it directly785descendants
- K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · cites it directly715descendants
- K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc. · 2002 · 2 generations on548descendants
- K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002 · 3 generations on426descendants
- K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · 4 generations on290descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955642 | Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| +1 | K993637 | N-395 Pulse Oximeter, with Extended Device Claims | Nellcor Puritan Bennett, Inc. | 1999 | 1 |
| +2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| +3 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| +4 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 28 | 0 |
| 2007 | 14 | 1 |
| 2008 | 24 | 0 |
| 2009 | 38 | 1 |
| 2010 | 37 | 1 |
| 2011 | 34 | 0 |
| 2012 | 38 | 0 |
| 2013 | 36 | 1 |
| 2014 | 36 | 2 |
| 2015 | 42 | 0 |
| 2016 | 34 | 0 |
| 2017 | 37 | 0 |
| 2018 | 42 | 0 |
| 2019 | 45 | 0 |
| 2020 | 36 | 0 |
| 2021 | 25 | 0 |
| 2022 | 44 | 0 |
| 2023 | 44 | 0 |
| 2024 | 37 | 0 |
| 2025 | 50 | 0 |
| 2026 | 31 | 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.
6 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K345847 | NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…blood pressure (on the N-3200 disclay/printer) When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K345847) is expanded to: e display and print out éssoéiated. pulse rate and systolic, diastolic and mean arterial blood pressure. The N… | |
| * | — | Datascope PASSPORT Named without a submission number | |
| * | — | Protocol Systems PROPAQ 104 Named without a submission number | |
| * | — | NELLCOR SYMPHONY™ N-3000 Pulse Oximeter Named without a submission number |
What descends from it? (817)
See all 8173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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.
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K991823 (Nellcor Puritan Bennett, Inc., 1999) has gone furthest, with 785 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The purpose and function of the N-3000E Patient Monitor is to: * noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpO₂ sensor), * noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads). When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to: display and print out associated ECG and plethysmographic waveforms…
Read the full statement (225 words)
The purpose and function of the N-3000E Patient Monitor is to:
* noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpO₂ sensor),
* noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads).
When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to:
display and print out associated ECG and plethysmographic waveforms, SpO₂, pulse rate and heart rate.
When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000E/N-3100/N-3200 is also to:
noninvasively and automatically measure systolic, diastolic and mean arterial blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 display/printer).
When the N-3100 is connected to the N-3200 Display/Printer, the purpose and function of the combined device (compared to K345847) is expanded to:
display and print out associated pulse rate and systolic, diastolic and mean arterial blood pressure.
The N-3000E Patient Monitor is intended for use in hospital, hospital-type and hospital transport environments as a “standalone” product and when connected to the N-3200 display/printer and/or the N-3100 blood pressure monitor. It is also intended for use to monitor neonatal, pediatric, or adult patients. The N-3000E, N-3200 and N-3100 are for prescription use only.
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/K955642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955642: Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955642
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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