510(k) · Cleared
ClearedFalcon/Xpress (Falcon/Xpress)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasonix, Ltd. · JOP Transducer, Ultrasonic
Cleared on Dec 18, 2024 as substantially equivalent to K111416 (Viasonix, Ltd., 2011) after a 105-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Dec 18, 2024
- Review
- 105 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904392 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904392 | Multilab 2000 | Unetixs, Inc. | 1991 | 4 |
| −1 | K111416 | Falcon | Viasonix, Ltd. | 2011 | — |
| 0 (this device) | K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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 K233976 VasoGuard (V10, V8, V6, V4, V2)score 8.0 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K111416 | FalconSummary page 5…mber: 21 CFR 870.2880 Product Code: JOP Device Class: Class II Predicate Devices: Falcon - K111416 2. DEVICE DESCRIPTION The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology… | 2011 |
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 33 years and passes through 2 companies; a new generation was cleared every 20.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K111416.
How does its category compare?
All JOP devicesJOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
The Falcon/Xpress is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The Falcon/Xpress is to be used only 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/K242662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242662: Falcon/Xpress (Falcon/Xpress).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242662
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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