510(k) · Cleared
ClearedNellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and 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 Nov 26, 1996 as substantially equivalent to K911598 (Datascope Corp., 1991) and 4 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 26, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K902730 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902730 SPO2 OptionProtocol Systems, Inc. · 1990
- This deviceK963400 Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200…Nellcor Puritan Bennett, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902730 | SPO2 Option | Protocol Systems, Inc. | 1990 | — |
| 0 (this device) | K963400 | Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200… | Nellcor Puritan Bennett, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 DPS? 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? (5)
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 |
|---|---|---|---|
| * | K911598 | Datascope Passport MonitorSummary page 2…scribed in the labeling and promotional literature for the predicate devices, as well as testing to accepted industry standards. (1) PASSPORT Monitor, Datascope Corp. , K911598. (2) PROPAQ 104 Ultra-Portable Patient Monitor with SpO2, Protocol Systems Inc., K902730. (3) ASSURANCE 2000 Monitor, EdenTec C… | 1991 |
| * | K902730 | SPO2 OptionSummary page 2…esting to accepted industry standards. (1) PASSPORT Monitor, Datascope Corp. , K911598. (2) PROPAQ 104 Ultra-Portable Patient Monitor with SpO2, Protocol Systems Inc., K902730. (3) ASSURANCE 2000 Monitor, EdenTec Corp., K905575 (4) NELLCOR SYMPHONY™ N-3000E Patient Monitor and N-3200 Display/Printer, N… | 1990 |
| * | K905575 | Modified Models 2000W and 2000W Option H Apnea MonSummary page 2…Monitor, Datascope Corp. , K911598. (2) PROPAQ 104 Ultra-Portable Patient Monitor with SpO2, Protocol Systems Inc., K902730. (3) ASSURANCE 2000 Monitor, EdenTec Corp., K905575 (4) NELLCOR SYMPHONY™ N-3000E Patient Monitor and N-3200 Display/Printer, Nellcor Puritan Bennett Incorporated, K955642. (5) NE… | 1991 |
| * | K955642 | Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/PrinterSummary page 2…730. (3) ASSURANCE 2000 Monitor, EdenTec Corp., K905575 (4) NELLCOR SYMPHONY™ N-3000E Patient Monitor and N-3200 Display/Printer, Nellcor Puritan Bennett Incorporated, K955642. (5) NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Patient M… | 1996 |
| * | K945947 | Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor…Summary page 2…HONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Patient Monitor, Nellcor Puritan Bennett, Incorporated, K955642.and K945947. Device Description: The device which is the subject of this submission comprises a patient monitor, namely, a Respiration Rate… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K911598.
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-3000 Patient Monitor is to: * noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpQO; sensor); * noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads). * noninvasively and continuously measure Respiration Rate. When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to: « display…
Read the full statement (212 words)
The purpose and function of the N-3000 Patient Monitor is to:
* noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpQO; sensor);
* noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads).
* noninvasively and continuously measure Respiration Rate.
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 Plethysmograhic waveforms, SpO2, pulse rate, heart rate and respiration rate.
When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000/N-3100/N-3200 is also to:
e 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).
The N-3000 Patient Monitor is intended for use in hospital and hospital-type 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 during hospital transport when connected to and operating off of the N-3000 and/or N-3200 internal battery, to monitor neonatal, pediatric, or adult patients. The N-3000, 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/K963400 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963400: Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and 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/K963400
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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