Cleared Traditional

K082196 - STATIC VESSEL ANALYZER

K082196 is an FDA 510(k) clearance for STATIC VESSEL ANALYZER, manufactured by Imedos GmbH. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K082196 · Imedos GmbH · Ophthalmic device
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Jun 2009
Decision
316d
Days
Class 2
Risk

K082196 is an FDA 510(k) clearance for the STATIC VESSEL ANALYZER. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Imedos GmbH (League City, US). The FDA issued a Cleared decision on June 16, 2009 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Imedos GmbH devices

FDA 510(k) Submission Details - K082196

510(k) Number K082196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date June 16, 2009
Days to Decision 316 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 110d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 82
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