510(k) · Cleared
ClearedAIM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inneroptic Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 13, 2012 as substantially equivalent to K083728 (Inneroptic Technology, Inc., 2009) after a 118-day review. Its family tree reaches back 3 generations to 1988. 5 later devices descend from it.
- Decided
- Sep 13, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K882383 (1988). 15 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 2 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- 1 generation backK083728 Invision SystemInneroptic Technology, Inc. · 2009
- This deviceK121479 AIMInneroptic Technology, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK141806 Clear Guide OneClear Guide Medical · 2014
- Descendant · cites it directly · 1 of its ownK132744 Acessa Guidance SystemHalt Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK211529 NAVIRFA ScopeNavifus Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK202119 AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK181124 Acessa ProVu SystemAcessa Health, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K141806Clear Guide OneClear Guide Medical · 2014 · cites it directly2descendants
- K132744Acessa Guidance SystemHalt Medical, Inc. · 2014 · cites it directly1descendant
- K211529NAVIRFA ScopeNavifus Corporation · 2022 · 2 generations on0descendants
- K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd. · 2020 · 2 generations on0descendants
- K181124Acessa ProVu SystemAcessa Health, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −2 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| −1 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| 0 (this device) | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
| +1 | K141806 | Clear Guide One | Clear Guide Medical | 2014 | — |
| +1 | K132744 | Acessa Guidance System | Halt Medical, Inc. | 2014 | — |
| +2 | K211529 | NAVIRFA Scope | Navifus Corporation | 2022 | — |
| +2 | K202119 | AcuSee AS-P1000 System | Weipeng (Suzhou) Medical Devices Co., Ltd. | 2020 | — |
| +2 | K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K083728 | Invision SystemSummary page 2…and indications for use of Aim are the same or similar to those found in the predicate device. Aim is substantially equivalent to InnerOptic's InVision System cleared in K083 728. The Aim device labeling contains instructions for use, including indications for use, cautions, contraindications, warnings and… | 2009 |
What descends from it? (5)
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 24 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K141806 (Clear Guide Medical, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083728.
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. 2012, 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?
Aim is indicated for enhancing 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 stereoscopic computer monitor screen 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 visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121479: AIM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121479
Report an extraction error
Are you the manufacturer?
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