510(k) · Cleared

Cleared

CA, Model: Cam

K071250510(k) TraditionalCleared Sep 28, 2007147-day reviewClass II21 CFR 886.1570

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

Optovue, Inc. · OBO Tomography, Optical Coherence

Cleared on Sep 28, 2007 as substantially equivalent to K062552 (Optovue, Inc., 2006) and 2 other predicates after a 147-day review. Its family tree reaches back 4 generations to 2002. 64 later devices descend from it.

Decided: Sep 28, 2007
Review: 147 days
Class: Class II
Product code: OBO
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K012727 (2002). 6 ancestors in all. 64 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
3 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
2 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
1 generation backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
This deviceK071250 CA, Model: CamOptovue, Inc. · 2007
Descendant · cites it directly · 58 of its ownK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
Descendant · 2 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 · 17 of its ownK120238 Rtvue XR OctOptovue, Inc. · 2012
Descendant · 3 generations on · 16 of its ownK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
Descendant · cites it directly · 16 of its ownK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2010high 9 (2024) · low 0 (2021)2026

Most influential descendants

Showing 5 of 64 · See all

K101505Rtvue Model Rtvue 100Optovue, Inc. · 2010 · cites it directly58descendants
K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 2 generations on24descendants
K120238Rtvue XR OctOptovue, Inc. · 2012 · 2 generations on17descendants
K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016 · 3 generations on16descendants
K091404Ivue, Model 100Optovue, Inc. · 2010 · cites it directly16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K012727	Humphrey OCT3	Carl Zeiss Ophthalmic Systems, Inc.	2002	—
−3	K030433	Stratusoct with RNFL Normative Database	Carl Zeiss Meditec, Inc.	2003	1
−2	K033123	Stratusoct with RNFL & Macula Normative Database	Carl Zeiss Meditec, Inc.	2004	1
−1	K063343	Bioptigen Spectral Domain Ophthalmic Imaging System	Bioptigen, Inc.	2006	—
0 (this device)	K071250	CA, Model: Cam	Optovue, Inc.	2007	—
+1	K101505	Rtvue Model Rtvue 100	Optovue, Inc.	2010	1
+2	K111157	CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and…	Carl Zeiss Meditec, Inc.	2012	—
+2	K120238	Rtvue XR Oct	Optovue, Inc.	2012	—
+3	K153080	RTVue XR OCT Avanti with AngioVue Software	Optovue, Inc.	2016	—
+1	K091404	Ivue, Model 100	Optovue, Inc.	2010	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K071250, 2002–2026Source: 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 OBO? 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 OBO device

#1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K062552	RTVUE Summary page 1 …Optical Coherence Tomography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Devices RTVue (K062552) - Optovue Visante OCT (K051789) - Carl Zeiss Meditec Bioptigen (K063343) - Bioptigen Inc. Intended Use The CA, an…	Optovue, Inc.	2006	—
*	K051789	Visante Oct Summary page 1 …ography (OCT) Classification Name: Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Devices RTVue (K062552) - Optovue Visante OCT (K051789) - Carl Zeiss Meditec Bioptigen (K063343) - Bioptigen Inc. Intended Use The CA, an auxiliary lens adapter, when used i…	Carl Zeiss Meditec, Inc.	2005	—
*	K063343	Bioptigen Spectral Domain Ophthalmic Imaging System Summary page 1 …Ophthalmoscope, a-c powered (21 CFR§ 886.1570) Predicate Devices RTVue (K062552) - Optovue Visante OCT (K051789) - Carl Zeiss Meditec Bioptigen (K063343) - Bioptigen Inc. Intended Use The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for i…	Bioptigen, Inc.	2006	—

Also cleared against K062552: 2 other devices →

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K101505	Rtvue Model Rtvue 100	Optovue, Inc.	2010	58
K091404	Ivue, Model 100	Optovue, Inc.	2010	16
K111505	Rtvue Cam with Corneal Power Upgrade	Optovue, Inc.	2011	8
K113129	Spectralis Anterior Segment Module (Spectralis Asm)	Heidelberg Engineering GmbH	2011	0
K100861	R T Vue with Software 5.0 Model: R I Vue 100	Optovue, Inc.	2010	0

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?

The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
2 of the 6 ancestors have a recall of any class.
Of its descendants, K101505 (Optovue, Inc., 2010) has gone furthest, with 58 descendants of its own.
2 other devices also cite its predicate K062552.

How does its category compare?

All OBO devices

OBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OBO

3in 2025

2007high 8 (2024) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBO

125in 2025

2007high 269 (2012) · low 87 (2018)2026

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

Recalls per year · OBO

1in 2022

2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · OBO

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code OBO, 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	2	—	0	0
2008	2	—	0	0
2009	4	151	0	0
2010	2	—	1	0
2011	2	—	2	0
2012	3	269	2	0
2013	2	—	0	2
2014	3	152	0	0
2015	1	—	0	0
2016	4	125	0	1
2017	4	118	0	0
2018	6	87	1	1
2019	5	249	0	0
2020	2	—	0	0
2021	1	—	1	1
2022	2	—	1	0
2023	7	262	0	3
2024	8	157	0	3
2025	3	125	0	4
2026	2	—	1	—

What is it indicated for?

The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071250 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071250: CA, Model: Cam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071250

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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