510(k) · Cleared
ClearedNAVIRFA Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navifus Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 5, 2022 as substantially equivalent to K141806 (Clear Guide Medical, 2014) after a 353-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- May 5, 2022
- Review
- 353 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K882383 (1988). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 4 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- 3 generations backK083728 Invision SystemInneroptic Technology, Inc. · 2009
- 2 generations backK121479 AIMInneroptic Technology, Inc. · 2012
- 1 generation backK141806 Clear Guide OneClear Guide Medical · 2014
- This deviceK211529 NAVIRFA ScopeNavifus Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −4 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| −3 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| −2 | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
| −1 | K141806 | Clear Guide One | Clear Guide Medical | 2014 | — |
| 0 (this device) | K211529 | NAVIRFA Scope | Navifus Corporation | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K141806 | Clear Guide OneSummary page 4…(21 CFR 892.1560, Product Code: IYO) Predicate Device Device Name: Clear Guide ONE 510(k) Number: K141806 Device Description The NAVIRFA Scope utilizes an optical camera and supporting software to integrate t… | 2014 |
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 34 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K141806.
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. 2022, 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 NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle.
The device is intended to be used in needle interventional procedures that already use ultrasound devices for visualization.
The device is intended for prescription use only.
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/K211529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211529: NAVIRFA Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211529
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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