510(k) Report

FDA applicant

Clarity Medical Systems

Pleasanton, CA4 decisions2008–20113 recalls

FDA records 4 decisions for Clarity Medical Systems (Pleasanton, CA) from 2008 to 2011: 4 510(k) clearances. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 5 predicates, 5 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Clarity Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12009: 22011: 1
2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2014

2012: 12014: 2
2008high 2 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Clarity Medical Systems by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clarity Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HKICamera, Ophthalmic, Ac-Powered4decisions

Who builds on its devices?

Later devices cite its devices 8 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081858Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 20083cite it
  • K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 20112cite it
  • K090326Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging SystemsClarity Medical Systems · 20092cite it
  • K083771Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 20091cites it

What has FDA decided for it lately?

  • K102859Retcam 3 Opthalmic Imaging SystemClarity Medical Systems · 20112 recalls
  • K090326Ret Cam II, Retcam 3 and Retcam Shuttle and Portable Ophthalmic Imaging SystemsClarity Medical Systems · 20092 recalls
  • K083771Retcam Portable Ophthalmic Imaging System, Model RCPClarity Medical Systems · 2009
  • K081858Retcam 3 Ophthalmic Imaging SystemClarity Medical Systems · 20083 recalls

All 4 as Clarity Medical Systems →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K081858Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton…Mar 7, 2014Class II
  • K081858RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems…Jan 24, 2014Class II
  • K081858Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775…Feb 2, 2012