510(k) · Cleared
ClearedAnsha Autonomic Nervous System Health Assessment Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtechs, LLC · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Feb 18, 2009 as substantially equivalent to K073323 (Medicore Co., Ltd., 2007) and 1 other predicate after a 64-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 64 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K853124 (1985). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- 2 generations backK023238 McpulseMeridian Co., Ltd. · 2003
- 1 generation backK073323 SA-3000PMedicore Co., Ltd. · 2007
- This deviceK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
- Descendant · cites it directly · 1 of its ownK101983 Critical Care AssessmentCritical Patient Care, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −2 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| −1 | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| 0 (this device) | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
| +1 | K101983 | Critical Care Assessment | Critical Patient Care, Inc. | 2010 | — |
| +1 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
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 JOM? 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 JOM device
- #1 K220527 PADnet Xpressscore 5.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073323 | SA-3000PSummary page 1…Trade Name: 'ANSHA' Common Name: Pneumatic Plethysmograph Substantial Equivalence: Medicore Co.Ltd. SA 3000P System K073323 QI-RV- 1 Hiealth Assessment System K080884 Reason for submission: Modification - additional… | 2007 |
| * | K080884 | QHRV 1 - Health Assessment SystemSummary page 1…Plethysmograph Substantial Equivalence: Medicore Co.Ltd. SA 3000P System K073323 QI-RV- 1 Hiealth Assessment System K080884 Reason for submission: Modification - additional features to existing product Performance: Th… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K101983 (Critical Patient Care, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOM devicesJOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JOM
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JOM
Too few JOM 510(k)s in any year since 2007 to give a median.
Recalls per year · JOM
No recall names JOM since 2007.
Adverse event reports per year · JOM
1in 2007
MAUDE reports naming product code JOM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ANSHA (QHRV1) is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate by electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083735: Ansha Autonomic Nervous System Health Assessment Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083735
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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