510(k) Report

510(k) · Cleared

Cleared

Ans 2000 Ecg Monitor and Respiration Pacer

K973426510(k) TraditionalCleared Aug 12, 1998336-day reviewClass II21 CFR 870.2340

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

D. E. Hokanson, Inc. · DPS Electrocardiograph

Cleared on Aug 12, 1998 after a 336-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.

Decided
Aug 12, 1998
Review
336 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

31 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2008: 4 descendants cleared1999: 1 descendant cleared2016: 3 descendants cleared2025: 1 descendant cleared2013: 1 descendant cleared2009: 1 descendant cleared2000: 1 descendant cleared2010: 2 descendants cleared2011: 3 descendants cleared2012: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared2021: 2 descendants cleared2014: 2 descendants cleared2023: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK973426 Ans 2000 Ecg Monitor and Respiration PacerD. E. Hokanson, Inc. · 1998
  2. Descendant · cites it directly · 26 of its ownK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
  3. Descendant · 2 generations on · 17 of its ownK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
  4. Descendant · 2 generations on · 16 of its ownK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
  5. Descendant · 3 generations on · 8 of its ownK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
  6. Descendant · 3 generations on · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12007: 22008: 42009: 12010: 22011: 32012: 22013: 12014: 22016: 32018: 12020: 12021: 22022: 12023: 12025: 12026: 2
1999high 4 (2008) · low 0 (2001)2026

Most influential descendants

Showing 5 of 31 · See all
  • K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999 · cites it directly26descendants
  • K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000 · 2 generations on17descendants
  • K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007 · 2 generations on16descendants
  • K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011 · 3 generations on8descendants
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973426Ans 2000 Ecg Monitor and Respiration PacerD. E. Hokanson, Inc.1998—
+1K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc.1999—
+2K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc.2000—
+2K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.2007—
+3K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH2011—
+3K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200720
200840
200910
201020
201130
201220
201310
201420
201630
201810
202010
202120
202210
202310
202510
202620
FIG. 1 — Lineage of K973426, 1998–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc.199926
K071168The Portable AnsiscopeDyansys, Inc.20077
K080884QHRV 1 - Health Assessment SystemMedtechs, LLC20083

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, K991831 (Boston Medical Technologies, Inc., 1999) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The ANS2000 is an ECC Monitor and Respiration Pacer that measures heart rate and provides a respiration timer for the purpose of measuring heart rate variations in response to respiration. The instrument was developed for use in studies of patients in which it is important to know the interval between heartbeats and also to synchronize the data analysis with the patient's breathing.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from D. E. Hokanson, Inc.

19 FDA decisions under this applicant name. See the company

  • K041689Polyurethane Blood Pressure CuffsD. E. Hokanson, Inc. · 2004
  • K033156OB1 Obstetrical DopplerD. E. Hokanson, Inc. · 2003
  • K023707A16 Blood Flow Measurement SystemD. E. Hokanson, Inc. · 2003
  • K982707EC6 PlethysmographD. E. Hokanson, Inc. · 1998
  • K970570NIVP3 (Windows Version of NivpD. E. Hokanson, Inc. · 1997

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https://510kreport.com/device/K973426 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973426: Ans 2000 Ecg Monitor and Respiration Pacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973426

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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