510(k) Report

510(k) · Cleared

Cleared

Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 Pulse Oximeter

K945947510(k) TraditionalCleared Mar 8, 199592-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nellcor, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 8, 1995 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 130 later devices descend from it.

Decided
Mar 8, 1995
Review
92 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

130 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared2003: 2 descendants cleared1997: 1 descendant cleared2004: 6 descendants cleared2005: 5 descendants cleared2006: 11 descendants cleared2010: 11 descendants cleared1999: 3 descendants cleared2008: 7 descendants cleared2007: 5 descendants cleared2009: 15 descendants cleared2013: 13 descendants cleared2012: 6 descendants cleared2002: 1 descendant cleared2011: 11 descendants cleared2014: 6 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2017: 5 descendants cleared2015: 2 descendants cleared2022: 3 descendants cleared2025: 5 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK945947 Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to…Nellcor, Inc. · 1995
  2. Descendant · cites it directly · 128 of its ownK952979 Hanc NetworkHealthtech Services Corp. · 1996
  3. Descendant · 2 generations on · 123 of its ownK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
  4. Descendant · 3 generations on · 103 of its ownK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
  5. Descendant · 4 generations on · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
  6. Descendant · 4 generations on · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

1996: 21997: 11999: 32002: 12003: 22004: 62005: 52006: 112007: 52008: 72009: 152010: 112011: 112012: 62013: 132014: 62015: 22016: 12017: 52018: 32020: 32022: 32023: 12024: 12025: 52026: 1
1996high 15 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 130 · See all
  • K952979Hanc NetworkHealthtech Services Corp. · 1996 · cites it directly128descendants
  • K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997 · 2 generations on123descendants
  • K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999 · 3 generations on103descendants
  • K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · 4 generations on98descendants
  • K031840Carematix Wellness SystemCarematix, Inc. · 2003 · 4 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945947Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the…Nellcor, Inc.1995—
+1K952979Hanc NetworkHealthtech Services Corp.1996—
+2K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc.1997—
+3K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co.1999—
+4K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems2002—
+4K031840Carematix Wellness SystemCarematix, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199930
200210
200320
200460
200550
2006110
200750
200870
2009150
2010110
2011110
201260
2013130
201460
201520
201610
201750
201830
202030
202230
202310
202410
202550
202610
FIG. 1 — Lineage of K945947, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DXN? 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 DXN device

  1. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (130)

See all 130

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K952979Hanc NetworkHealthtech Services Corp.1996128
K963400Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200 Display/PrinterNellcor Puritan Bennett, Inc.19960

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, K952979 (Healthtech Services Corp., 1996) has gone furthest, with 128 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

More from Nellcor, Inc.

18 FDA decisions under this applicant name. See the company

  • K953472Nellcor Symphony N-3100 Blood Pressure MonitorNellcor, Inc. · 1995
  • K952316Nellcor Symphony N-3000 Pulse OximeterNellcor, Inc. · 1995
  • K952222Nellcor N-20PA Portable Pulse OximeterNellcor, Inc. · 1995
  • K942347Nellcor Symphony Pulse Oximeter Model N-3000Nellcor, Inc. · 1995
  • K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K945947 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945947: Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 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/K945947

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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