510(k) Report

510(k) · Cleared

Cleared

Zoll Rescuenet Epcr Model Rescuenet Epcr

K103473510(k) TraditionalCleared May 13, 2011170-day reviewClass II21 CFR 870.2450

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

ZOLL Medical Corporation · DXJ Display, Cathode-Ray Tube, Medical

Cleared on May 13, 2011 as substantially equivalent to K100272 (Philips Medical Systems, 2010) after a 170-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.

Decided
May 13, 2011
Review
170 days
Class
Class II
Product code
DXJ
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K941811 (1994). 16 ancestors in all, the oldest K822695 (1982). 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1993: 1 other ancestor1992: 3 other ancestors1982: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2014: 2 descendants cleared2013: 1 descendant clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×2: 2 generations cleared close together, K981376 (1999), K990125 (1999) K992636 · HP Carevue 9000 Clinical Information System, Model M2331A · Hewlett-Packard Co. · 1999 · recalledK100272 · Intellivue Clinical Information Portfolio · Philips Medical Systems · 2010 · recalled19801990200020102020
  1. Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 2 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
  6. 1 generation backK100272 Intellivue Clinical Information PortfolioPhilips Medical Systems · 2010 · Recalled
  7. This deviceK103473 Zoll Rescuenet Epcr Model Rescuenet EpcrZOLL Medical Corporation · 2011
  8. Descendant · cites it directly · 0 of its ownK132488 Zoll Code WriterZOLL Medical Corporation · 2014
  9. Descendant · cites it directly · 0 of its ownK131272 Siren Epcr SuiteMedusa Medical Technologies, Inc. · 2014
  10. Descendant · cites it directly · 0 of its ownK131919 Zoll Epcr IosZOLL Medical Corporation · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K132488Zoll Code WriterZOLL Medical Corporation · 2014 · cites it directly0descendants
  • K131272Siren Epcr SuiteMedusa Medical Technologies, Inc. · 2014 · cites it directly0descendants
  • K131919Zoll Epcr IosZOLL Medical Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−5K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−4K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−3K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−2K992636HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co.19998
−1K100272Intellivue Clinical Information PortfolioPhilips Medical Systems20102
0 (this device)K103473Zoll Rescuenet Epcr Model Rescuenet EpcrZOLL Medical Corporation2011—
+1K132488Zoll Code WriterZOLL Medical Corporation2014—
+1K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.2014—
+1K131919Zoll Epcr IosZOLL Medical Corporation2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199230
199310
199410
199510
199610
199710
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
FIG. 1 — Lineage of K103473, 1994–2014Source: 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), 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 DXJ? 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 DXJ device

  1. #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100272Intellivue Clinical Information Portfolio
Summary page 6
…ueNet ePOR are substantially equivalent to the corresponding features and functions of the Philips Medical Systems IntelliVue Clinical Information Portfolio (K100272, cleared for use on 4/14/20 10). Comparison of Technological Characteristics RescueNet ePCR features and functions a…
Philips Medical Systems20102

Also cleared against K100272: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K132488Zoll Code WriterZOLL Medical Corporation20140
K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.20140
K131919Zoll Epcr IosZOLL Medical Corporation20130

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?

  • The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 16 ancestors have a recall of any class.
  • Of its descendants, K132488 (ZOLL Medical Corporation, 2014) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K100272.

How does its category compare?

All DXJ devices

DXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DXJ

2in 2021

2007: 12008: 12010: 22011: 42012: 12013: 32014: 42015: 22016: 12017: 42018: 42020: 12021: 22026 (partial year): 1
2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXJ

130in 2018

2011: 53 days median2013: 174 days median2014: 242 days median2017: 164 days median2018: 130 days median
2007high 242 (2014) · low 53 (2011)2026

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

Recalls per year · DXJ

2in 2025

2008: 22009: 82010: 12011: 12022: 12025: 2
2007high 8 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXJ

3in 2025

2007: 32008: 52009: 292010: 1482011: 1292012: 212013: 42014: 132015: 152016: 72017: 102018: 32019: 292020: 222021: 62022: 22023: 172024: 152025: 3
2007high 148 (2010) · low 2 (2022)2025

MAUDE reports naming product code DXJ, 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
20071—03
20081—25
20090—829
20102—1148
20114531129
20121—021
2013317404
20144242013
20152—015
20161—07
20174164010
2018413003
20190—029
20201—022
20212—06
20220—12
20230—017
20240—015
20250—23
20261—0—

What is it indicated for?

RescueNet ePOR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePOR is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. RescueNet ePOR is indicated for use by health care providers whenever there is a need for generation of a patient record.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K103473: Zoll Rescuenet Epcr Model Rescuenet Epcr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103473

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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