510(k) Report

510(k) · Cleared

Cleared

Zymed Holter Scanner Model 2010

K955015510(k) TraditionalCleared Mar 18, 1996138-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

Zymed Medical Instrumentation · DQK Computer, Diagnostic, Programmable

Cleared on Mar 18, 1996 as substantially equivalent to K930806 (Agilent Technologies, 1994) after a 138-day review. Its family tree reaches back 1 generation to 1994. 108 later devices descend from it.

Decided
Mar 18, 1996
Review
138 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K930806 (1994). 108 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 4 descendants cleared2001: 7 descendants cleared2002: 4 descendants cleared2004: 2 descendants cleared2009: 3 descendants cleared2025: 8 descendants cleared2015: 7 descendants cleared2007: 3 descendants cleared2005: 4 descendants cleared2020: 7 descendants cleared2006: 1 descendant cleared2010: 3 descendants cleared2014: 4 descendants cleared2008: 2 descendants cleared2022: 5 descendants cleared2012: 2 descendants cleared2011: 2 descendants cleared2016: 7 descendants cleared2013: 3 descendants cleared2018: 2 descendants cleared2017: 7 descendants cleared2021: 4 descendants cleared2019: 4 descendants cleared2026: 4 descendants cleared2023: 7 descendants cleared2024: 2 descendants clearedK930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 19941990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 9 descendants4 generations forward: 14 descendants5 generations forward: 19 descendants6 generations forward: 14 descendants7 generations forward: 19 descendants8 generations forward: 9 descendants9 generations forward: 6 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant K930806 · Zymed Holter Scanner Model 2010 · Agilent Technologies · 19940+5+10
  1. Root · 1 generation backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
  2. This deviceK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
  3. Descendant · cites it directly · 89 of its ownK990170 Holter 2000Zymed Medical Instrumentation · 1999
  4. Descendant · 2 generations on · 85 of its ownK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
  5. Descendant · 3 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
  6. Descendant · 4 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  7. Descendant · 4 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

1999: 42001: 72002: 42004: 22005: 42006: 12007: 32008: 22009: 32010: 32011: 22012: 22013: 32014: 42015: 72016: 72017: 72018: 22019: 42020: 72021: 42022: 52023: 72024: 22025: 82026: 4
1999high 8 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 108 · See all
  • K990170Holter 2000Zymed Medical Instrumentation · 1999 · cites it directly89descendants
  • K0109492010 Plus Holter for WindowsAgilent Technologies · 2001 · 2 generations on85descendants
  • K042108Vista PlusNovacor · 2005 · 3 generations on46descendants
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 4 generations on40descendants
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 4 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930806Zymed Holter Scanner Model 2010Agilent Technologies1994—
0 (this device)K955015Zymed Holter Scanner Model 2010Zymed Medical Instrumentation1996—
+1K990170Holter 2000Zymed Medical Instrumentation1999—
+2K0109492010 Plus Holter for WindowsAgilent Technologies2001—
+3K042108Vista PlusNovacor2005—
+4K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+4K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199940
200170
200240
200420
200540
200610
200730
200820
200930
201030
201120
201220
201330
201440
201570
201670
201770
201820
201940
202070
202140
202250
202370
202420
202580
202640
FIG. 1 — Lineage of K955015, 1994–2026Source: 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), 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 26.7 · 28 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
*K930806Zymed Holter Scanner Model 2010
Summary page 1
…Classification Name: Arrhythmia Detector/Medical Cathode-Ray Tube Display Legally marketed device to which S.E. is claimed: ¢ Zymed Holter Scanner Model 2010; 510(k) #K930806 Description: A Zymed Holter Scanner system consists of a series of interface devices to include a central monitoring computerize…
Agilent Technologies1994—

Also cleared against K930806: 1 other device →

What descends from it? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K990170Holter 2000Zymed Medical Instrumentation199989
K983102Cardiac Diagnostic System Model CH 2000Cambridge Heart, Inc.19999
K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996
K004017H-ScribeMortara Instrument, Inc.20014
K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021

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?

  • Its one ancestor has no recall.
  • Of its descendants, K990170 (Zymed Medical Instrumentation, 1999) has gone furthest, with 89 descendants of its own.
  • 1 other device also cites its predicate K930806.

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?

The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the “muscle” to analyze even the most difficult recordings quickly and accurately. Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts, trend data analysis, HRV…

Read the full statement (162 words)

The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the “muscle” to analyze even the most difficult recordings quickly and accurately.

Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts, trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance.

The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or. the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.

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

Also cleared against K930806

1 other device cites the same predicate.

  • K980186Zymed Telemetry SystemAgilent Technologies · 1998

More from Zymed Medical Instrumentation

7 FDA decisions under this applicant name. See the company

  • K002004ZYBITZymed Medical Instrumentation · 2000
  • K992197Modification to Zymed Holter 2000Zymed Medical Instrumentation · 1999
  • K990170Holter 2000Zymed Medical Instrumentation · 1999
  • K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999
  • K951370Zymed Telemetry System; Model T8010Zymed Medical Instrumentation · 1995

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The DQK category page

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https://510kreport.com/device/K955015 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955015: Zymed Holter Scanner Model 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955015

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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