510(k) Report

510(k) · Cleared

Cleared

DGH-500 Pachymeter

K920906510(k) TraditionalCleared Nov 2, 1992249-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dgh Technology, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Nov 2, 1992 after a 249-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 21 later devices descend from it.

Decided
Nov 2, 1992
Review
249 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

21 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1998: 1 descendant cleared2003: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2024: 1 descendant cleared2004: 1 descendant cleared2012: 1 descendant cleared2021: 2 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
  2. Descendant · cites it directly · 11 of its ownK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
  3. Descendant · 2 generations on · 10 of its ownK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
  4. Descendant · 3 generations on · 7 of its ownK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
  5. Descendant · cites it directly · 7 of its ownK993674 Pocket Ultrasonic PachymeterQuantel Medical · 2000
  6. Descendant · 2 generations on · 3 of its ownK094038 Compact TouchQuantel S.A. · 2010

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998: 12000: 12003: 22004: 12008: 12009: 12010: 22012: 12013: 12015: 12016: 12018: 32020: 12021: 22024: 12025: 1
1998high 3 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 21 · See all
  • K980357Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998 · cites it directly11descendants
  • K062763Noncon Robo Pachy F&aKonan Medical, Inc. · 2008 · 2 generations on10descendants
  • K120264Konan Specular Microscope XivKonan Medical, Inc. · 2012 · 3 generations on7descendants
  • K993674Pocket Ultrasonic PachymeterQuantel Medical · 2000 · cites it directly7descendants
  • K094038Compact TouchQuantel S.A. · 2010 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920906DGH-500 PachymeterDgh Technology, Inc.1992—
+1K980357Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc.1998—
+2K062763Noncon Robo Pachy F&aKonan Medical, Inc.2008—
+3K120264Konan Specular Microscope XivKonan Medical, Inc.2012—
+1K993674Pocket Ultrasonic PachymeterQuantel Medical2000—
+2K094038Compact TouchQuantel S.A.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200320
200410
200810
200910
201020
201210
201310
201510
201610
201830
202010
202120
202410
202510
FIG. 1 — Lineage of K920906, 1992–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980357Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc.199811
K993674Pocket Ultrasonic PachymeterQuantel Medical20007
K033385DGH 55 Handheld Pachymeter (Pachmate)Dgh Technology, Inc.20030

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, K980357 (Konan, Inc., 1998) has gone furthest, with 11 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Dgh Technology, Inc.

7 FDA decisions under this applicant name. See the company

  • K171301Scanmate FlexDgh Technology, Inc. · 2017
  • K093371Model DGH 6000 Scanmate aDgh Technology, Inc. · 2010
  • K033385DGH 55 Handheld Pachymeter (Pachmate)Dgh Technology, Inc. · 2003
  • K965127DGH Model 9000Dgh Technology, Inc. · 1997
  • K913067DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992

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https://510kreport.com/device/K920906 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920906: DGH-500 Pachymeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920906

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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