510(k) · Cleared
ClearedVitalScan ANS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medeia, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Jan 15, 2020 as substantially equivalent to K083735 (Medtechs, LLC, 2009) and 2 other predicates after a 250-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jan 15, 2020
- Review
- 250 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K853124 (1985). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- 4 generations backK023238 McpulseMeridian Co., Ltd. · 2003
- 3 generations backK073323 SA-3000PMedicore Co., Ltd. · 2007
- 2 generations backK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
- 1 generation backK101983 Critical Care AssessmentCritical Patient Care, Inc. · 2010
- This deviceK191266 VitalScan ANSMedeia, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −4 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| −3 | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| −2 | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
| −1 | K101983 | Critical Care Assessment | Critical Patient Care, Inc. | 2010 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K083735 | Ansha Autonomic Nervous System Health Assessment PlusSummary page 4…Noninvasive blood pressure measurement system 21 CFR 870.1130 (DXN) a3 PREDICATE DEVICES: Primary Predicate Device: K083735; ANSHA‐QHRV1 Secondary Predicate Device: K101983; Critical Care Assessment Secondary Predicate Device: K172655; A… | 2009 |
| * | K101983 | Critical Care AssessmentSummary page 4…21 CFR 870.1130 (DXN) a3 PREDICATE DEVICES: Primary Predicate Device: K083735; ANSHA‐QHRV1 Secondary Predicate Device: K101983; Critical Care Assessment Secondary Predicate Device: K172655; ABPI MD Reference Device: K012647; Tono… | 2010 |
| * | K172655 | Automated ankle brachial pressure index measuring deviceSummary page 4…CES: Primary Predicate Device: K083735; ANSHA‐QHRV1 Secondary Predicate Device: K101983; Critical Care Assessment Secondary Predicate Device: K172655; ABPI MD Reference Device: K012647; Tonoport V The FDA database for recalls was searched on 20 March… | 2018 |
| † | K012647 | Tonoport V | 2001 |
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 35 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K083735.
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. 2020, 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?
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems. VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index…
Read the full statement (121 words)
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.
VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).
The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191266: VitalScan ANS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191266
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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