510(k) · Cleared
ClearedDGH-4000 a-Scan/Pachymeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dgh Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 31, 1992 after a 204-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 31, 1992
- Review
- 204 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK913067 DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK043287 Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK063472 Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100…Meda, Ltd. · 2007
- Descendant · 3 generations on · 1 of its ownK121243 Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013
- Descendant · 4 generations on · 0 of its ownK152318 MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK012803 AL-2000 Combined Biometer and PachymeterTomey Corp. · 2002
Most influential descendants
Showing 5 of 5 · See all- K043287Palmscan AP2000; Palmscan A2000; Palmscan P2000Micromedical Devices, Inc. · 2004 · cites it directly3descendants
- K063472Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200Meda, Ltd. · 2007 · 2 generations on2descendants
- K121243Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterMEDA Co., Ltd. · 2013 · 3 generations on1descendant
- K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyMEDA Co., Ltd. · 2015 · 4 generations on0descendants
- K012803AL-2000 Combined Biometer and PachymeterTomey Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913067 | DGH-4000 a-Scan/Pachymeter | Dgh Technology, Inc. | 1992 | — |
| +1 | K043287 | Palmscan AP2000; Palmscan A2000; Palmscan P2000 | Micromedical Devices, Inc. | 2004 | — |
| +2 | K063472 | Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200 | Meda, Ltd. | 2007 | — |
| +3 | K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter | MEDA Co., Ltd. | 2013 | — |
| +4 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015 | — |
| +1 | K012803 | AL-2000 Combined Biometer and Pachymeter | Tomey Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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, K043287 (Micromedical Devices, Inc., 2004) 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 | — |
https://510kreport.com/device/K913067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913067: DGH-4000 a-Scan/Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913067
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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