510(k) · Cleared
ClearedClear Guide One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clear Guide Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 19, 2014 as substantially equivalent to K121479 (Inneroptic Technology, Inc., 2012) after a 78-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 78 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882383 (1988). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 3 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- 2 generations backK083728 Invision SystemInneroptic Technology, Inc. · 2009
- 1 generation backK121479 AIMInneroptic Technology, Inc. · 2012
- This deviceK141806 Clear Guide OneClear Guide Medical · 2014
- Descendant · cites it directly · 0 of its ownK211529 NAVIRFA ScopeNavifus Corporation · 2022
- Descendant · cites it directly · 0 of its ownK202119 AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd. · 2020
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 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −3 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| −2 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| −1 | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
| 0 (this device) | K141806 | Clear Guide One | Clear Guide Medical | 2014 | — |
| +1 | K211529 | NAVIRFA Scope | Navifus Corporation | 2022 | — |
| +1 | K202119 | AcuSee AS-P1000 System | Weipeng (Suzhou) Medical Devices Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K121479 | AIMSummary page 4…onic pulsed echo imaging system 21 CFR § 892.1560 (Product Code IYO) Predicate Device Information Device Name AIM 510(k) Number K121479 Device Description The Clear Guide ONE is a medical device that tracks instrument positioning during ultrasound-guided procedur… | 2012 |
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 26 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K211529 (Navifus Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121479.
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 Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141806: Clear Guide One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141806
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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