510(k) Report

510(k) · Cleared

Cleared

Synescope, Easyscope, Synecom, Holterreader

K042002510(k) TraditionalCleared Oct 20, 200486-day reviewClass II21 CFR 870.1425

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

Ela Medical, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Oct 20, 2004 as substantially equivalent to K002817 (Ela Medical, Inc., 2001) and 5 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.

Decided
Oct 20, 2004
Review
86 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K930806 (1994). 21 ancestors in all, the oldest K871344 (1987). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1999: 1 other ancestor1995: 4 other ancestors1990: 3 other ancestors1997: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1987: 2 other ancestors2020: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 1994K955015 · Zymed Holter Scanner Model 2010 · Zymed Medical Instrumentation · 1996K982090 · Paceart Home Trak Plus Easi Event Recorder System · Paceart, Inc. · 1999K020213 · Netlink/Netscan · Rozinn Electronics, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K020213 · Netlink/Netscan · Rozinn Electronics, Inc. · 2002K982090 · Paceart Home Trak Plus Easi Event Recorder System · Paceart, Inc. · 1999K955015 · Zymed Holter Scanner Model 2010 · Zymed Medical Instrumentation · 1996K930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 19940
  1. Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
  2. 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
  3. 2 generations backK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
  4. 1 generation backK020213 Netlink/NetscanRozinn Electronics, Inc. · 2002
  5. This deviceK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
  6. Descendant · cites it directly · 2 of its ownK193177 CER-SCardiocalm · 2020
  7. Descendant · 2 generations on · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
  8. Descendant · 3 generations on · 0 of its ownK243312 CER-SCardiocalm Srl · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K193177CER-SCardiocalm · 2020 · cites it directly2descendants
  • K213861CER-SCardiocalm Srl · 2022 · 2 generations on1descendant
  • K243312CER-SCardiocalm Srl · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K930806Zymed Holter Scanner Model 2010Agilent Technologies1994—
−3K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation1996—
−2K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.1999—
−1K020213Netlink/NetscanRozinn Electronics, Inc.2002—
0 (this device)K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.2004—
+1K193177CER-SCardiocalm2020—
+2K213861CER-SCardiocalm Srl2022—
+3K243312CER-SCardiocalm Srl2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198720
199030
199220
199410
199540
199610
199710
199910
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
202510
FIG. 1 — Lineage of K042002, 1994–2025Source: 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 DQK? 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 DQK device

  1. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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
*K002817Synetec
Summary page 1
…870.1425 Predicate devices: The legally marketed devices to which ELA Medical is claiming equivalence are: - SyneTec (ELA Medical): ELA Medical "SyneTec TM" (510(k) K002817, ELA Medical Inc.). - SyneView (ELA Medical): ELA Medical "SyneView TM" (510(k) K990727, ELA Medical Inc.) includin…
Ela Medical, Inc.2001—
*K990727Syneflash & Syneview
Summary page 1
…quivalence are: - SyneTec (ELA Medical): ELA Medical "SyneTec TM" (510(k) K002817, ELA Medical Inc.). - SyneView (ELA Medical): ELA Medical "SyneView TM" (510(k) K990727, ELA Medical Inc.) including SyneView2 TM . - H-Scribe (Mortara): Mortara Instrument, Inc. "H-Scribe" (510(k) K0040…
Ela Medical, Inc.1999—
*K004017H-Scribe
Summary page 1
…l): ELA Medical "SyneView TM" (510(k) K990727, ELA Medical Inc.) including SyneView2 TM . - H-Scribe (Mortara): Mortara Instrument, Inc. "H-Scribe" (510(k) K004017, Mortara Instrument, Inc.). Holter For Windows + (Rozinn): Rozinn Electronics, Inc. "Holter For…
Mortara Instrument, Inc.20012
*K930564Holter for Windows
Summary page 2
…017, Mortara Instrument, Inc.). Holter For Windows + (Rozinn): Rozinn Electronics, Inc. "Holter For Windows +" (based on 510(k) K930564, Northeast Monitoring, Inc.) including also Rozinn Electronics, Inc. "Netlink/NetScan" (5 10(k) K0202 13, Rozinn Electro…
North East Monitoring, Inc.1995—
*K020213Netlink/Netscan
Summary page 2
…s, Inc. "Holter For Windows +" (based on 510(k) K930564, Northeast Monitoring, Inc.) including also Rozinn Electronics, Inc. "Netlink/NetScan" (5 10(k) K0202 13, Rozinn Electronics, Inc.). Mida (Ortivus sold by Philips Medical Systems): based on "Mida System Models 1000/…
Rozinn Electronics, Inc.2002—
*K896396Mida System, Models 1000/1100
Summary page 2
…etScan" (5 10(k) K0202 13, Rozinn Electronics, Inc.). Mida (Ortivus sold by Philips Medical Systems): based on "Mida System Models 1000/1100" (5 10(k) K896396, Medical Graphics Corp.) Device description: SyneScopeT M , EasyScopeT M , SyncCorn ' and HolterReader are software applications…
Medical Graphics Corp.1990—

Also cleared against K002817: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193177CER-SCardiocalm20202

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 10 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 21 ancestors have a recall of any class.
  • Of its descendants, K193177 (Cardiocalm, 2020) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K002817.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

SyneScope is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by: - SpiderView Holter ECG recorder (K032466), - SyneFlash Holter ECG (K990727), or - other compatible cassette tape recorder. In addition, any ISHNE compatible recording can be read by SyneScope. EasyScope is intended to analyze, edit, review, report, store and…

Read the full statement (232 words)

SyneScope is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

- SpiderView Holter ECG recorder (K032466),

- SyneFlash Holter ECG (K990727), or

- other compatible cassette tape recorder.

In addition, any ISHNE compatible recording can be read by SyneScope.

EasyScope is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

- SpiderView Holter ECG recorder (K032466),

- SyneFlash Holter ECG (K990727), or

- other compatible cassette tape recorder.

SyneCom is intended to download, transfer for analysis, print and store multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

- SpiderView Holter ECG recorder (K032466),

- SyneFlash Holter ECG (K990727)

HolterReader is intended to view and print Holter reports from SyneScope, EasyScope and SyneCom.

SyneScope, EasyScope, SyneCom and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:

* Patient symptoms such as syncope, dizziness or palpitations.

* Ischemia, especially in patients who cannot exercise or in patients with variant angina.

* Function of an implanted pacemaker or defibrillator.

Indications for use as stated in the FDA summary.

Also cleared against K002817

1 other device cites the same predicate.

More from Ela Medical, Inc.

43 FDA decisions under this applicant name. See the company

  • K032466SpiderviewEla Medical, Inc. · 2003
  • K002817SynetecEla Medical, Inc. · 2001
  • K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000
  • K000029Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000
  • K990727Syneflash & SyneviewEla Medical, Inc. · 1999

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https://510kreport.com/device/K042002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042002: Synescope, Easyscope, Synecom, Holterreader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042002

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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