510(k) · Cleared
ClearedAccusonic a-Scan Model, 24-4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutome, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 10, 2003 as substantially equivalent to K960765 (Mentor Ophthalmics, Inc., 1996) and 3 other predicates after an 18-day review. Its family tree reaches back 2 generations to 1987. 17 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 18 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K871536 (1987). 5 ancestors in all, the oldest K860757 (1986). 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
- 1 generation backK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
- This deviceK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · cites it directly14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 2 generations on10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 3 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 2 generations on4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871536 | Ophthasonic a-Scan/ B-Scan | Teknar, Inc. | 1987 | — |
| −1 | K960765 | Mentor Advent a/B System | Mentor Ophthalmics, Inc. | 1996 | — |
| 0 (this device) | K032956 | Accusonic a-Scan Model, 24-4000 | Accutome, Inc. | 2003 | — |
| +1 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +2 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +3 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +3 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 | 2 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960765 | Mentor Advent a/B SystemSummary page 1…on: System, Imaging, Pulsed Echo, Ultrasonic (see: 21 CFR 892.1560) Product Code: IYO Panel: 90 Legally Marketed Accutome Advent AB (K960765) previously by Mentor Predicate Devices: Ophthalmics and acquired by Accutome in December of 1999. (Ho… | 1996 |
| * | K860757 | Ophthasonic a-ScanSummary page 1…by Accutome in December of 1999. (However, the AccuSonic A-Scan does not function as a B-Scan.); Teknar Ophthasonic A-Scan (K860757); Teknar Opthasonic A/P 111 (K903666); DGH 3000A A- Scan (K872726); DGH 4000 A-Scan… | 1986 |
| * | K903666 | Ophthasonic a/P IiiSummary page 1…ever, the AccuSonic A-Scan does not function as a B-Scan.); Teknar Ophthasonic A-Scan (K860757); Teknar Opthasonic A/P 111 (K903666); DGH 3000A A- Scan (K872726); DGH 4000 A-ScanFach (IS9 13067) Description of the The AccuSonic A-Sca… | 1990 |
| * | K872726 | DGH-3000A a-ScanSummary page 1…as a B-Scan.); Teknar Ophthasonic A-Scan (K860757); Teknar Opthasonic A/P 111 (K903666); DGH 3000A A- Scan (K872726); DGH 4000 A-ScanFach (IS9 13067) Description of the The AccuSonic A-Scan device is designed as a biometer, Device:… | 1987 |
| Kept off the family tree | K991306 | DGH 4000 A-ScanFach Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (17)
See all 172 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 16 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K082891 (Haag-Streit AG, 2009) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K960765.
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?
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032956: Accusonic a-Scan Model, 24-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032956
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