510(k) · Cleared
ClearedSonic Window
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 4, 2014 as substantially equivalent to K100919 (B-K Medical Aps, 2011) and 1 other predicate after a 47-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 4, 2014
- Review
- 47 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000567 (2000). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 3 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 2 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 1 generation backK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
- This deviceK140126 Sonic WindowAnalogic Corporation · 2014
- Descendant · cites it directly · 0 of its ownK243479 EchoGuide (Version 1)Sonavex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK161342 Sonic WindowAnalogic Corporation · 2016
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 |
|---|---|---|---|---|---|
| −4 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −3 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −2 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −1 | K081154 | Ultrasound Scanner Flex Focus, Model 1202 | B-K Medical Aps | 2008 | — |
| 0 (this device) | K140126 | Sonic Window | Analogic Corporation | 2014 | — |
| +1 | K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025 | — |
| +1 | K161342 | Sonic Window | Analogic Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202Summary page 2…Tasue 5. Predicate Devices: The legally marketed devices tawhich equivalence is being claimed are: The Flex Focus cleared under Premarket Notification K 100919 (Summary is included in Appendix C along with the User Guide, the Transducer User Guide and Transducer Data Sheet). T… | 2011 |
| * | K081154 | Ultrasound Scanner Flex Focus, Model 1202Summary page 4…Sonic Window Flex Focus New Device K 100919 w/ 8820E 7 Featres Idicatons 081154 for Contact Featues IdicaionsMaterials (Probe 8848)… | 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 14 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K243479 (Sonavex, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K100919.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Sonic Window is intended for the visualization of vessels, and vascular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140126: Sonic Window.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140126
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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