510(k) · Cleared
ClearedMentor Advent a/B System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Ophthalmics, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 8, 1996 as substantially equivalent to K871536 (Teknar, Inc., 1987) after a 164-day review. Its family tree reaches back 1 generation to 1987. 21 later devices descend from it.
- Decided
- Aug 8, 1996
- Review
- 164 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871536 (1987). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
- This deviceK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
- Descendant · cites it directly · 17 of its ownK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
- Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 3 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 4 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · 3 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K032956Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003 · cites it directly17descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 3 generations on10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 4 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871536 | Ophthasonic a-Scan/ B-Scan | Teknar, Inc. | 1987 | — |
| 0 (this device) | K960765 | Mentor Advent a/B System | Mentor Ophthalmics, Inc. | 1996 | — |
| +1 | K032956 | Accusonic a-Scan Model, 24-4000 | Accutome, Inc. | 2003 | — |
| +2 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +3 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +4 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +3 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K871536 | Ophthasonic a-Scan/ B-ScanSummary page 1…g, Ophthalmic (86 HPR) ubstantial Equiva Claim The substantial equivalence device selected for comparison to this device is Teknar A/B III. Its 510(k) control number is K871536. Device Description MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versat… | 1987 |
What descends from it? (21)
See all 212 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?
- Its one ancestor has no recall.
- Of its descendants, K032956 (Accutome, Inc., 2003) has gone furthest, with 17 descendants of its own.
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.
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?
MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
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/K960765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960765: Mentor Advent a/B System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960765
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