510(k) · Cleared
ClearedCompact Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel S.A. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 22, 2010 as substantially equivalent to K051851 (Quantel Medical, 2005) and 1 other predicate after a 113-day review. Its family tree reaches back 3 generations to 1993. 3 later devices descend from it.
- Decided
- Apr 22, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926251 (1993). 7 ancestors in all, the oldest K920906 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK926251 B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc. · 1993
- 2 generations backK021683 Cinescan SQuantel Medical · 2002
- 1 generation backK051851 Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005
- This deviceK094038 Compact TouchQuantel S.A. · 2010
- Descendant · cites it directly · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
- Descendant · 2 generations on · 0 of its ownK213254 Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021
- Descendant · cites it directly · 0 of its ownK102027 Axis Nano Opthalmic Biometer Ultrasound SystemQuantel Medical S.A. · 2010
Most influential descendants
Showing 3 of 3 · See all- K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · cites it directly1descendant
- K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021 · 2 generations on0descendants
- K102027Axis Nano Opthalmic Biometer Ultrasound SystemQuantel Medical S.A. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926251 | B-Scan Opthalmic Ultrasound Imaging System | Biovision, Inc. | 1993 | — |
| −2 | K021683 | Cinescan S | Quantel Medical | 2002 | — |
| −1 | K051851 | Aviso Ophthalmic Ultrasound System | Quantel Medical | 2005 | — |
| 0 (this device) | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| +1 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018 | — |
| +2 | K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021 | — |
| +1 | K102027 | Axis Nano Opthalmic Biometer Ultrasound System | Quantel Medical S.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K051851 | Aviso Ophthalmic Ultrasound SystemSummary page 2…redicate Devices [21 CFR 807.92(a)(3)] The Compact TOUCH uses similar technology and physical output characteristics as the following predicate devices: k051851 Quantel Medical A VISO Ophthalmic Ultrasound System k993674 Quantel Medical POCKET Ultrasonic Pachymeter E. Device Descr… | 2005 |
| * | K993674 | Pocket Ultrasonic PachymeterSummary page 2…s similar technology and physical output characteristics as the following predicate devices: k051851 Quantel Medical A VISO Ophthalmic Ultrasound System k993674 Quantel Medical POCKET Ultrasonic Pachymeter E. Device Description [21 CFR 807.92(a)(4)] The Compact TOUCH is an ultraso… | 2000 |
What descends from it? (3)
2 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 17 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K180265 (Quantel Medical, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051851.
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. 2010, 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 QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
* Visualization of the interior of the eye and the orbit by A and B scans.
* Axial Length measurement of the eye by ultrasonic means.
* Implanted IOL power calculation, using the Axial Length measurement.
* Measurement of corneal thickness by ultrasonic means.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094038: Compact Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094038
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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