510(k) Report

510(k) · Cleared

Cleared

Centra II Analysis System

K922171510(k) TraditionalCleared Dec 28, 1992234-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

Marquette Electronics, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Dec 28, 1992 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.

Decided
Dec 28, 1992
Review
234 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
0

65 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2005: 2 descendants cleared2003: 1 descendant cleared2009: 1 descendant cleared2004: 2 descendants cleared2006: 1 descendant cleared2008: 2 descendants cleared2015: 5 descendants cleared2010: 1 descendant cleared2007: 2 descendants cleared2014: 4 descendants cleared2013: 1 descendant cleared2011: 2 descendants cleared2020: 4 descendants cleared2012: 1 descendant cleared2017: 7 descendants cleared2016: 4 descendants cleared2018: 2 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared2022: 2 descendants cleared2021: 4 descendants cleared2019: 3 descendants cleared2023: 6 descendants cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
  2. Descendant · cites it directly · 64 of its ownK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
  3. Descendant · 2 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
  4. Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  5. Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
  6. Descendant · 4 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12004: 22005: 22006: 12007: 22008: 22009: 12010: 12011: 22012: 12013: 12014: 42015: 52016: 42017: 72018: 22019: 32020: 42021: 42022: 22023: 62024: 12025: 22026: 4
1999high 7 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 65 · See all
  • K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999 · cites it directly64descendants
  • K042108Vista PlusNovacor · 2005 · 2 generations on46descendants
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
  • K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 4 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922171Centra II Analysis SystemMarquette Electronics, Inc.1992—
+1K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn1999—
+2K042108Vista PlusNovacor2005—
+3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—
+4K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200420
200520
200610
200720
200820
200910
201010
201120
201210
201310
201440
201550
201640
201770
201820
201930
202040
202140
202220
202360
202410
202520
202640
FIG. 1 — Lineage of K922171, 1992–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn199964

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, K991786 (General Electric Medical Systems Information Techn, 1999) has gone furthest, with 64 descendants of its own.

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—

More from Marquette Electronics, Inc.

82 FDA decisions under this applicant name. See the company

  • K971868Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
  • K971683Wireless Lan (Local Area Network) - Wireless EthernetMarquette Electronics, Inc. · 1997
  • K972199Signal-Averaged High Resolution P Wave AnalysisMarquette Electronics, Inc. · 1997
  • K962547Cardioserv PMarquette Electronics, Inc. · 1997
  • K963120Responder 2500 Defibrillator and Cardiac Care SystemMarquette Electronics, Inc. · 1997

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The DQK category page

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https://510kreport.com/device/K922171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922171: Centra II Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922171

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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