510(k) · Cleared
ClearedPocket Ultrasonic Pachymeter
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 Jul 13, 2000 as substantially equivalent to K924311 (Sonomed, Inc., 1992) and 1 other predicate after a 255-day review. Its family tree reaches back 1 generation to 1992. 7 later devices descend from it.
- Decided
- Jul 13, 2000
- Review
- 255 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920906 (1992). 2 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- This deviceK993674 Pocket Ultrasonic PachymeterQuantel Medical · 2000
- Descendant · cites it directly · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010
- Descendant · 2 generations on · 1 of its ownK180265 COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018
- Descendant · cites it directly · 0 of its ownK232302 Pocket IIIQuantel Medical · 2024
- Descendant · 3 generations on · 0 of its ownK213254 Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021
- Descendant · 2 generations on · 0 of its ownK102027 Axis Nano Opthalmic Biometer Ultrasound SystemQuantel Medical S.A. · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K094038Compact TouchQuantel S.A. · 2010 · cites it directly3descendants
- K180265COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical · 2018 · 2 generations on1descendant
- K232302Pocket IIIQuantel Medical · 2024 · cites it directly0descendants
- K213254Axialis Ophthalmic Ultrasound SystemQuantel Medical · 2021 · 3 generations on0descendants
- K102027Axis Nano Opthalmic Biometer Ultrasound SystemQuantel Medical S.A. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| 0 (this device) | K993674 | Pocket Ultrasonic Pachymeter | Quantel Medical | 2000 | — |
| +1 | K094038 | Compact Touch | Quantel S.A. | 2010 | — |
| +2 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018 | — |
| +1 | K232302 | Pocket III | Quantel Medical | 2024 | — |
| +3 | K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021 | — |
| +2 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K924311 | Sonomed 4000P Ultrasonic PachymeterSummary page 1…Corneal thickness Classification name: System, Imaging, Ultrasonic, Ophthalmic, 980IYO (3) Equivalent legally-marketed devices. 1. Sonomed 200P Ultrasonic Pachymeter, K924311 2. DGH Model 500 Pachymeter, K920906 (4) Description The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that use… | 1992 |
| * | K920906 | DGH-500 PachymeterSummary page 1…e: System, Imaging, Ultrasonic, Ophthalmic, 980IYO (3) Equivalent legally-marketed devices. 1. Sonomed 200P Ultrasonic Pachymeter, K924311 2. DGH Model 500 Pachymeter, K920906 (4) Description The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ult… | 1992 |
What descends from it? (7)
4 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K094038 (Quantel S.A., 2010) has gone furthest, with 3 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 | — |
What is it indicated for?
The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be used for the measurement of corneal thickness by ultrasonic means, which is required for some types of corneal surgery.
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/K993674 · printed Nov 3, 2026
Cite this page
510(k) Report. “K993674: Pocket Ultrasonic Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K993674
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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