510(k) · Cleared
ClearedUbm Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutome, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 14, 2011 as substantially equivalent to K070943 (Accutome Ultrasound, Inc., 2007) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 14, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960622 (1996). 7 ancestors in all, the oldest K871536 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK960622 I-SCANOphthalmic Technologies, Inc. · 1996
- 3 generations backK030770 Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003
- 2 generations backK031391 HF Module with TransducersOphthalmic Technologies, Inc. · 2003
- 1 generation backK092837 Oti-Scan 3000Opko Instrumentation, Inc. · 2009
- This deviceK103471 Ubm PlusAccutome, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960622 | I-SCAN | Ophthalmic Technologies, Inc. | 1996 | — |
| −3 | K030770 | Oti Scan with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| −2 | K031391 | HF Module with Transducers | Ophthalmic Technologies, Inc. | 2003 | — |
| −1 | K092837 | Oti-Scan 3000 | Opko Instrumentation, Inc. | 2009 | — |
| 0 (this device) | K103471 | Ubm Plus | Accutome, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070943 | B-Scan PlusSummary page 1…sound Transducer (21 CFR 892.1570, Product Code: ITX) Legally Marketed Predicate Devices: Accutomec B-Scan Plus (K(070943) OT1-Scan 3000 (K(092837) Description of the Device: The UBM Plus device is designe… | 2007 |
| * | K092837 | Oti-Scan 3000Summary page 1…892.1570, Product Code: ITX) Legally Marketed Predicate Devices: Accutomec B-Scan Plus (K(070943) OT1-Scan 3000 (K(092837) Description of the Device: The UBM Plus device is designed as a high frequency ult… | 2009 |
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 15 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K070943.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment 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/K103471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103471: Ubm Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103471
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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