510(k) · Cleared

Cleared

Visucam

K021787510(k) SpecialCleared Jun 21, 200222-day reviewClass I21 CFR 892.2010

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

Carl Zeiss Ophthalmic Systems, Inc. · NFF Device, Storage, Images, Ophthalmic

Cleared on Jun 21, 2002 as substantially equivalent to K011877 (Carl Zeiss Jena GmbH, 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 74 later devices descend from it.

Decided: Jun 21, 2002
Review: 22 days
Class: Class I
Product code: NFF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011877 (2001). 74 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011877 FF450 Plus Fundus Camera and Visupac Digital Image Archiving System…Carl Zeiss Jena GmbH · 2001
This deviceK021787 VisucamCarl Zeiss Ophthalmic Systems, Inc. · 2002
Descendant · cites it directly · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
Descendant · 2 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
Descendant · 3 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
Descendant · 2 generations on · 22 of its ownK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
Descendant · cites it directly · 22 of its ownK043222 Viscucam C Digital CameraCarl Zeiss Meditec, AG · 2005

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2005high 9 (2018) · low 0 (2007)2026

Most influential descendants

Showing 5 of 74 · See all

K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · cites it directly63descendants
K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 2 generations on41descendants
K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 3 generations on24descendants
K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009 · 2 generations on22descendants
K043222Viscucam C Digital CameraCarl Zeiss Meditec, AG · 2005 · cites it directly22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011877	FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450…	Carl Zeiss Jena GmbH	2001	—
0 (this device)	K021787	Visucam	Carl Zeiss Ophthalmic Systems, Inc.	2002	—
+1	K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	2006	—
+2	K101223	Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra…	Heidelberg Engineering	2010	—
+3	K111157	CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and…	Carl Zeiss Meditec, Inc.	2012	—
+2	K092374	Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan	Ophthalmic Imaging Systems	2009	—
+1	K043222	Viscucam C Digital Camera	Carl Zeiss Meditec, AG	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	0
2009	2	0
2010	2	0
2011	1	0
2012	3	0
2013	2	0
2014	4	0
2015	4	0
2016	3	0
2017	3	0
2018	9	0
2019	7	0
2020	3	0
2021	4	0
2022	1	0
2023	5	0
2024	7	0
2025	7	0
2026	3	0

FIG. 1 — Lineage of K021787, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K011877	FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus…	Carl Zeiss Jena GmbH	2001	—

Also cleared against K011877: 7 other devices →

What descends from it? (74)

See all 74

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

Number	Device	Applicant	Decided	Descendants
K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	2006	63
K043222	Viscucam C Digital Camera	Carl Zeiss Meditec, AG	2005	22
K053044	Opto Global Digital Fundus Camera System Model Ads 1.5	Opto Global, Inc.	2006	4

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?

Its one ancestor has no recall.
Of its descendants, K062295 (Medivision Medical Imaging, Ltd., 2006) has gone furthest, with 63 descendants of its own.
7 other devices also cite its predicate K011877.

How does its category compare?

All NFF devices

NFF Device, Storage, Images, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFF

FDA has decided no NFF device since 2007.

Median 510(k) review, days · NFF

Too few NFF 510(k)s in any year since 2007 to give a median.

Recalls per year · NFF

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · NFF

No MAUDE report names NFF since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	1	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The VISUCAMlite Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021787 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021787: Visucam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021787

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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