510(k) · Cleared
ClearedA-Scan Plus Connect
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 Jan 29, 2013 as substantially equivalent to K032956 (Accutome, Inc., 2003) after a 90-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Jan 29, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871536 (1987). 6 ancestors in all, the oldest K860757 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
- 2 generations backK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
- 1 generation backK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
- This deviceK123349 A-Scan Plus ConnectAccutome, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK152573 4SightAccutome, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K1525734SightAccutome, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871536 | Ophthasonic a-Scan/ B-Scan | Teknar, Inc. | 1987 | — |
| −2 | K960765 | Mentor Advent a/B System | Mentor Ophthalmics, Inc. | 1996 | — |
| −1 | K032956 | Accusonic a-Scan Model, 24-4000 | Accutome, Inc. | 2003 | — |
| 0 (this device) | K123349 | A-Scan Plus Connect | Accutome, Inc. | 2013 | — |
| +1 | K152573 | 4Sight | Accutome, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K032956 | Accusonic a-Scan Model, 24-4000Summary page 1…System, Imaging, Pulsed Echo, Ultrasonic (21 CFR 892.1560, Product Code: IYO) Diagnostic Ultrasound Transducer (21 CFR. 892.1570, Product Code: ITX) Accusonic A-Scan (K032956) *There have been no prior FDA submissions for the A-Scan Plus Connect. The Accutome A-Scan Plus Connect device is designed as a… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152573 | 4Sight | 2015 | 0 |
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 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K152573 (Accutome, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032956.
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. 2013, 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?
This 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123349 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123349: A-Scan Plus Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123349
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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