510(k) · Cleared

Cleared

Retcam Portable Ophthalmic Imaging System, Model RCP

K083771510(k) SpecialCleared Jan 30, 200943-day reviewClass II21 CFR 886.1120

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

Clarity Medical Systems · HKI Camera, Ophthalmic, Ac-Powered

Cleared on Jan 30, 2009 as substantially equivalent to K081858 (Clarity Medical Systems, 2008) after a 43-day review. Its family tree reaches back 1 generation to 2008. 8 later devices descend from it.

Decided: Jan 30, 2009
Review: 43 days
Class: Class II
Product code: HKI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K081858 (2008). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK081858 Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 2008 · Recalled
This deviceK083771 Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
Descendant · cites it directly · 7 of its ownK090326 Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic…Clarity Medical Systems · 2009 · Recalled
Descendant · 2 generations on · 4 of its ownK102859 Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · Recalled
Descendant · 3 generations on · 3 of its ownK170527 Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017
Descendant · 3 generations on · 1 of its ownK183059 3nethra neoForus Health Pvt.Ltd · 2018
Descendant · 2 generations on · 1 of its ownK182263 RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009high 2 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all

K090326Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging SystemsClarity Medical Systems · 2009 · cites it directly7descendants
K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 2011 · 2 generations on4descendants
K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical · 2017 · 3 generations on3descendants
K1830593nethra neoForus Health Pvt.Ltd · 2018 · 3 generations on1descendant
K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K081858	Retcam 3 Ophthalmic Imaging System	Clarity Medical Systems	2008	3
0 (this device)	K083771	Retcam Portable Ophthalmic Imaging System, Model RCP	Clarity Medical Systems	2009	—
+1	K090326	Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems	Clarity Medical Systems	2009	2
+2	K102859	Retcam 3 Opthalmic Imaging System	Clarity Medical Systems	2011	2
+3	K170527	Phoenix Clinical ICON	Phoenix Technology Group, Inc. Dba Phoenix Clinical	2017	—
+3	K183059	3nethra neo	Forus Health Pvt.Ltd	2018	—
+2	K182263	RetCam 3 ; RetCam Shuttle ; RetCam Portable	Natus Medical Incorporated	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2017	1	0
2018	2	0
2021	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K083771, 2008–2025Source: 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 HKI? 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 HKI device

#1 K253176 TearViewscore 12.7 · 5 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? (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
*	K081858	Retcam 3 Ophthalmic Imaging System Summary page 1 …ss: Class 1I Classification Panel: Ophthalmology' Product Code(s): HKI Equivalent Predicate Device: RetCam Shuttle Ophthalmic Imaging System, K08 1858 Device Description: The RetCamn Portable Imaging System is designed to quickly and easily capture wide field, dig…	Clarity Medical Systems	2008	3

Also cleared against K081858: 2 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090326	Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging Systems	Clarity Medical Systems	2009	7

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 a recall.
Of its descendants, K090326 (Clarity Medical Systems, 2009) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K081858.

How does its category compare?

All HKI devices

HKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HKI

4in 2025

2007high 11 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HKI

167in 2025

2007high 259 (2023) · low 28 (2024)2026

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

Recalls per year · HKI

1in 2018

2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · HKI

1in 2023

2007high 66 (2016) · low 0 (2010)2025

MAUDE reports naming product code HKI, 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	3
2008	5	29	0	1
2009	11	104	0	1
2010	6	140	0	0
2011	7	160	0	0
2012	5	179	1	2
2013	7	141	0	22
2014	4	135	0	3
2015	0	—	0	3
2016	4	146	1	66
2017	2	—	1	20
2018	6	71	1	14
2019	4	73	0	0
2020	5	182	0	5
2021	4	155	0	3
2022	1	—	0	1
2023	5	259	0	1
2024	3	28	0	0
2025	4	167	0	0
2026	2	—	0	—

What is it indicated for?

The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083771 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083771: Retcam Portable Ophthalmic Imaging System, Model RCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083771

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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