510(k) · Cleared
ClearedFlochec Photo Plethysmographic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vascular Dynamics · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Feb 12, 2010 as substantially equivalent to K982707 (D. E. Hokanson, Inc., 1998) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 12, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944495 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K143094QuantaFloSemler Scientific, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944495 | Model 3200 Vascular Mini-Lab | Parks Medical Electronics, Inc. | 1995 | 1 |
| 0 (this device) | K093192 | Flochec Photo Plethysmographic Device | Advanced Vascular Dynamics | 2010 | — |
| +1 | K143094 | QuantaFlo | Semler Scientific, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K982707 | EC6 PlethysmographSummary page 1…thcare practioner. The submitted device is expected to retain the same classification as the predicate device, Hokanson Delie model EC-6 Plethysmograph, 510(k) number 1(982707. This device carries the classification of Class 2, Poctcode JOM. Refer to section 2.1 of this 510OK for the description of the… | 1998 |
| * | K944495 | Model 3200 Vascular Mini-LabSummary page 1…Checm Photoplethysmnographic Device. Revised 510OK Summiary Herbert J. Semler December 21, 2009 Predicate Devices - Hokanson EC-6 (K9882707), Parks Medical Mini-Lab (K(944495) The FloChec Plethysmograph Device (PPG) is similar to the PPCG portion of the Hokanson EC-6 but dots not include a strain gauge… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143094 | QuantaFlo | 2015 | 0 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K143094 (Semler Scientific, Inc., 2015) has gone furthest, with 0 descendants 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. 2010, 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?
To monitor relative blood flow changes distal to the occlusion of a brachial, radial, ulnar, or femoral artery.
From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.
The device is for adult use and not for pediatric or fetal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093192: Flochec Photo Plethysmographic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093192
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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