510(k) · Cleared
ClearedHF Module with Transducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Technologies, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 20, 2003 as substantially equivalent to K030770 (Ophthalmic Technologies, Inc., 2003) after a 49-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 20, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960622 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960622 I-SCANOphthalmic Technologies, Inc. · 1996
- 1 generation backK030770 Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003
- This deviceK031391 HF Module with TransducersOphthalmic Technologies, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK092837 Oti-Scan 3000Opko Instrumentation, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK103471 Ubm PlusAccutome, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996 | — |
| −1 | K030770 | Oti Scan with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| 0 (this device) | K031391 | HF Module with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| +1 | K092837 | Oti-Scan 3000 | Opko Instrumentation, Inc. | 2009 | — |
| +2 | K103471 | Ubm Plus | Accutome, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K030770 | Oti Scan with TransducersSummary page 2…-9 OTI HF Module Page A 3 ( 5 ) Intended Use The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications. (6) Performance Data… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092837 | Oti-Scan 3000 | 2009 | 1 |
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 7 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092837 (Opko Instrumentation, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030770.
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?
Transducer for B-scans with OTI-Scan HF Module
Transducer for B-scans with OTI-Scan HF Module ophthalmic system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031391: HF Module with Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031391
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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