510(k) Report

510(k) · Cleared

Cleared

QANS (Quantitative Autonomic Nervous System) Monitoring System

K142551510(k) TraditionalCleared Apr 16, 2015218-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

Hhssystems, LLC · DPS Electrocardiograph

Cleared on Apr 16, 2015 as substantially equivalent to K903497 (Thought Technology, Ltd., 1991) and 2 other predicates after a 218-day review. Its family tree reaches back 4 generations to 1992.

Decided
Apr 16, 2015
Review
218 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K922171 (1992). 14 ancestors in all, the oldest K881905 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestor2004: 1 other ancestor2001: 2 other ancestors1995: 3 other ancestors2000: 1 other ancestor1988: 2 other ancestorsK922171 · Centra II Analysis System · Marquette Electronics, Inc. · 1992K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 1999K021230 · HERO · Medical Decision Networks · 2003K062068 · Intelwave Heart Rate Variability System, Version 1.0 · Intelwave, LLC · 20061985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 6 other ancestors K062068 · Intelwave Heart Rate Variability System, Version 1.0 · Intelwave, LLC · 2006K021230 · HERO · Medical Decision Networks · 2003K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 1999K922171 · Centra II Analysis System · Marquette Electronics, Inc. · 19920
  1. Root · 4 generations backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
  2. 3 generations backK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
  3. 2 generations backK021230 HEROMedical Decision Networks · 2003
  4. 1 generation backK062068 Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC · 2006
  5. This deviceK142551 QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922171Centra II Analysis SystemMarquette Electronics, Inc.1992—
−3K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn1999—
−2K021230HEROMedical Decision Networks2003—
−1K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC2006—
0 (this device)K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198820
199110
199530
200010
200120
200410
FIG. 1 — Lineage of K142551, 1992–2015Source: 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 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
Get a 510(k) Report

What was it cleared against? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K903497Flexcomp DSP & Procomp
Summary page 5
…or safety and accuracy 1. Thought Technology ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp 2 Encoder systems --K903497. 2. using BioGraph Infiniti and CardioPro software -- K972723. Note: All of the para…
Thought Technology, Ltd.1991—
Kept off the family treeK972723FDA’s K972723 is Bio Trol
Our reading of the summary gave K972723, FDA’s number for Bio Trol (Mindmedia Labs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioGraph Infiniti and CardioPro software”. Kept off the family tree.
Summary page 5
…FlexComp Infiniti, ProComp5 and ProComp 2 Encoder systems --K903497. 2. using BioGraph Infiniti and CardioPro software -- K972723. Note: All of the parameters that are recorded by the QANS system are recorded by th…
Mindmedia Labs, Inc.1997—
*K021230HERO
Summary page 5
…system are recorded by the Thought Technology devices. For monitoring functions: 1. HeRO ™ HRV analysis system (510(k) K021230). 2. Intelwave Heart Rate Variability System (510(k) K062068) Device Description: The HHSsystems QANS Mo…
Medical Decision Networks2003—
*K062068Intelwave Heart Rate Variability System, Version 1.0
Summary page 5
…For monitoring functions: 1. HeRO ™ HRV analysis system (510(k) K021230). 2. Intelwave Heart Rate Variability System (510(k) K062068) Device Description: The HHSsystems QANS Monitoring System is the same as that of the Thought Technology…
Intelwave, LLC2006—

Also cleared against K903497: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 23 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K903497.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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 intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System) Monitoring System: QANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, and muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and…

Read the full statement (132 words)

The intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System)

Monitoring System:

QANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological

monitoring device that collects and transmits measurements (heart rate, respiration rate,

and muscle activity) using sensors. The QANS monitoring system monitors the

sympathetic and parasympathetic nervous system using accurate recordings of heart rate

(HR) from EKG and provides statistical data as well as heart rate variability (HRV) data

which the clinician can use it make clinical assessments of medical, dental or peak

performance interventions.

The physiological information can be used as a general patient monitoring system as well

as for research. QANS is not intended to produce any interpretation of the measurements

obtained and does not provide any type of diagnosis.

Patients should be 5 years old or older.

Indications for use as stated in the FDA summary.

Also cleared against K903497

2 other devices cite the same predicate.

  • K122879EEGER4 Model 4.3Eeg Software, LLC · 2013
  • K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 20081 recall

Recent decisions in DPS

The DPS category page

  • K260640Kinetic Software LibraryMonebo Technologies, Inc. · 2026
  • K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc. · 2026
  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K142551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142551: QANS (Quantitative Autonomic Nervous System) Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142551

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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