510(k) Report

510(k) · Cleared

Cleared

Heart Rate Variability Software Option

K950779510(k) TraditionalCleared Apr 25, 199563-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

Spacelabs, Inc. · DPS Electrocardiograph

Cleared on Apr 25, 1995 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 96 later devices descend from it.

Decided
Apr 25, 1995
Review
63 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1999: 2 descendants cleared2007: 4 descendants cleared2008: 6 descendants cleared2010: 3 descendants cleared2011: 5 descendants cleared2012: 3 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2009: 2 descendants cleared2004: 2 descendants cleared2006: 1 descendant cleared2015: 5 descendants cleared2014: 6 descendants cleared2016: 7 descendants cleared2025: 3 descendants cleared2013: 2 descendants cleared2023: 7 descendants cleared2018: 3 descendants cleared2000: 1 descendant cleared2020: 5 descendants cleared2022: 3 descendants cleared2021: 6 descendants cleared2017: 7 descendants cleared2026: 5 descendants cleared2019: 3 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
  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 · cites it directly · 31 of its ownK972991 Monitor One NDXQmed, Inc. · 1998
  6. Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22000: 12003: 12004: 22005: 22006: 12007: 42008: 62009: 22010: 32011: 52012: 32013: 22014: 62015: 52016: 72017: 72018: 32019: 32020: 52021: 62022: 32023: 72024: 12025: 32026: 5
1998high 7 (2016) · low 0 (2001)2026

Most influential descendants

Showing 5 of 96 · 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
  • K972991Monitor One NDXQmed, Inc. · 1998 · cites it directly31descendants
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950779Heart Rate Variability Software OptionSpacelabs, Inc.1995—
+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—
+1K972991Monitor One NDXQmed, Inc.1998—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200010
200310
200420
200520
200610
200740
200860
200920
201030
201150
201230
201320
201460
201550
201670
201770
201830
201930
202050
202160
202230
202370
202410
202530
202650
FIG. 1 — Lineage of K950779, 1995–2026Source: 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (96)

See all 96

3 later devices cite 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
K972991Monitor One NDXQmed, Inc.199831
K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.200716

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 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—

More from Spacelabs, Inc.

46 FDA decisions under this applicant name. See the company

  • K954962Spacelabs Medical Multigas AnalyzerSpacelabs, Inc. · 1996
  • K951605Spacelabs Medical Casemaster Information Management SystemSpacelabs, Inc. · 1995
  • K941165Comet Capnograph ModuleSpacelabs, Inc. · 1994
  • K923788Space Labs Model 90560Spacelabs, Inc. · 1993
  • K912742Esophageal Stethoscope Temperature ProbeSpacelabs, Inc. · 1992

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https://510kreport.com/device/K950779 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950779: Heart Rate Variability Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950779

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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