510(k) · Cleared
ClearedPocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantel Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 14, 2000 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Mar 14, 2000
- Review
- 25 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK000554 Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for…Quantel Medical · 2000
- Descendant · cites it directly · 7 of its ownK021683 Cinescan SQuantel Medical · 2002
- Descendant · 2 generations on · 6 of its ownK051851 Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005
- Descendant · 3 generations on · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010
- Descendant · 4 generations on · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
- Descendant · cites it directly · 1 of its ownK093371 Model DGH 6000 Scanmate aDgh Technology, Inc. · 2010
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K021683Cinescan SQuantel Medical · 2002 · cites it directly7descendants
- K051851Aviso Ophthalmic Ultrasound SystemQuantel Medical · 2005 · 2 generations on6descendants
- K094038Compact TouchQuantel S.A. · 2010 · 3 generations on3descendants
- K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · 4 generations on1descendant
- K093371Model DGH 6000 Scanmate aDgh Technology, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000554 | Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket | Quantel Medical | 2000 | — |
| +1 | K021683 | Cinescan S | Quantel Medical | 2002 | — |
| +2 | K051851 | Aviso Ophthalmic Ultrasound System | Quantel Medical | 2005 | — |
| +3 | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| +4 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018 | — |
| +1 | K093371 | Model DGH 6000 Scanmate a | Dgh Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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?
- Of its descendants, K021683 (Quantel Medical, 2002) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K000554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K000554: Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer for Pocket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K000554
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026