510(k) · Cleared

Cleared

DGH-3000A a-Scan

K872726510(k) TraditionalCleared Dec 4, 1987149-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 Dec 4, 1987 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Dec 4, 1987
Review: 149 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

20 later devices descend from it, 2 citing it directly.

This deviceK872726 DGH-3000A a-ScanDgh Technology, Inc. · 1987
Descendant · cites it directly · 17 of its ownK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
Descendant · 3 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
Descendant · 4 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
Descendant · 3 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2003high 3 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 20 · See all

K032956Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003 · cites it directly17descendants
K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 3 generations on10descendants
K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 4 generations on9descendants
K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872726	DGH-3000A a-Scan	Dgh Technology, Inc.	1987	—
+1	K032956	Accusonic a-Scan Model, 24-4000	Accutome, Inc.	2003	—
+2	K082891	Lenstar, Model LS900	Haag-Streit AG	2009	3
+3	K101182	Iolmaster 500	Carl Zeiss Meditec, AG	2010	4
+4	K122418	Iolmaster 500	Carl Zeiss Meditec, AG	2013	4
+3	K143275	IOLMaster700	Carl Zeiss Meditec, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2009	1	0
2010	2	0
2013	2	0
2014	1	0
2015	3	0
2016	1	0
2017	2	0
2018	1	0
2019	2	0
2020	1	0
2021	1	0
2025	2	0

FIG. 1 — Lineage of K872726, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K032956	Accusonic a-Scan Model, 24-4000	Accutome, Inc.	2003	17
K093371	Model DGH 6000 Scanmate a	Dgh Technology, Inc.	2010	1

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, K032956 (Accutome, Inc., 2003) has gone furthest, with 17 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

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

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

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

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/K872726 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872726: DGH-3000A a-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872726

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026