510(k) · Cleared
Cleared4Sight
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 Nov 25, 2015 as substantially equivalent to K123349 (Accutome, Inc., 2013) and 2 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Nov 25, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K871536 (1987). 10 ancestors in all, the oldest K810660 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
- 3 generations backK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
- 2 generations backK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
- 1 generation backK123349 A-Scan Plus ConnectAccutome, Inc. · 2013
- This deviceK152573 4SightAccutome, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871536 | Ophthasonic a-Scan/ B-Scan | Teknar, Inc. | 1987 | — |
| −3 | K960765 | Mentor Advent a/B System | Mentor Ophthalmics, Inc. | 1996 | — |
| −2 | K032956 | Accusonic a-Scan Model, 24-4000 | Accutome, Inc. | 2003 | — |
| −1 | K123349 | A-Scan Plus Connect | Accutome, Inc. | 2013 | — |
| 0 (this device) | K152573 | 4Sight | Accutome, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K123349 | A-Scan Plus ConnectSummary page 5…rasound Transducer (21 CFR 892.1570, Product Code: ITX) Legally Marketed Predicate Devices: A-Scan Plus Connect (K123349) B-scan Plus (K070943) Accupach V Pachymeter (K042752)… | 2013 |
| * | K070943 | B-Scan PlusSummary page 5…CFR 892.1570, Product Code: ITX) Legally Marketed Predicate Devices: A-Scan Plus Connect (K123349) B-scan Plus (K070943) Accupach V Pachymeter (K042752) • No prior FDA subm… | 2007 |
| * | K042752 | Accupach VSummary page 5…s: A-Scan Plus Connect (K123349) B-scan Plus (K070943) Accupach V Pachymeter (K042752) • No prior FDA submissions have been submitted for a… | 2004 |
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 28 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 10 ancestors has a recall.
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. 2015, 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 4Sight is a multi-purpose diagnostic ophthalmic ultrasound system intended to make axial length, anterior chamber depth, lens thickness and corneal thickness measurements of the eye and visualize the internal structure of 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/K152573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152573: 4Sight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152573
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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