510(k) · Cleared
ClearedFalcon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasonix, Ltd. · JOP Transducer, Ultrasonic
Cleared on Jul 15, 2011 as substantially equivalent to K002766 (Nicolet Biomedical, 2000) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Jul 15, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904392 (1991). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK904392 Multilab 2000Unetixs, Inc. · 1991 · Recalled
- This deviceK111416 FalconViasonix, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK131623 Smartdop XTKoven Technology, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK242662 Falcon/Xpress (Falcon/Xpress)Viasonix, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233976 VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK153762 Smartdop XT6Koven Technology, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK131860 Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingUs Vascular, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K131623Smartdop XTKoven Technology, Inc. · 2014 · cites it directly1descendant
- K242662Falcon/Xpress (Falcon/Xpress)Viasonix, Ltd. · 2024 · cites it directly0descendants
- K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC · 2024 · cites it directly0descendants
- K153762Smartdop XT6Koven Technology, Inc. · 2016 · 2 generations on0descendants
- K131860Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingUs Vascular, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904392 | Multilab 2000 | Unetixs, Inc. | 1991 | 4 |
| 0 (this device) | K111416 | Falcon | Viasonix, Ltd. | 2011 | — |
| +1 | K131623 | Smartdop XT | Koven Technology, Inc. | 2014 | — |
| +1 | K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix, Ltd. | 2024 | — |
| +1 | K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | 2024 | — |
| +2 | K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016 | — |
| +1 | K131860 | Vasculab VL4000 Photoplethysmograph with Pulse Volume Recording | Us Vascular, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 2 | 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 JOP? 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 JOP device
- #1 K242662 Falcon/Xpress (Falcon/Xpress)score 8.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K002766 | Nicolet VasoguardSummary page 6…on/Pro Falcon/Quad Falcon/ABJ+ (Nicolet, Series 11 Carefusion) (Unetixs) 5 10(k) K002766 K904392 this this this number application… | 2000 |
| * | K904392 | Multilab 2000Summary page 6…n/Quad Falcon/ABJ+ (Nicolet, Series 11 Carefusion) (Unetixs) 5 10(k) K002766 K904392 this this this number application application… | 1991 |
What descends from it? (5)
4 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K131623 (Koven Technology, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOP devicesJOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JOP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JOP
Too few JOP 510(k)s in any year since 2007 to give a median.
Recalls per year · JOP
No recall names JOP since 2007.
Adverse event reports per year · JOP
2in 2025
MAUDE reports naming product code JOP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive
evaluation of peripheral vascular pathology in patients.
The devices are not intended to replace other means of evaluating vital patient
physiological processes, are not intended to be used in fetal applications, and are not
intended to be used inside the sterile field.
They are to be used by trained medical personnel in hospitals, clinics and physicians
offices by prescription or doctor's orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111416 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111416: Falcon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111416
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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