Cleared Traditional

K800140 - SILASTIC SCLERAL SPONGE II W/CIRCLING BD (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800140 · Dow Corning Corp. Healthcare Industries Materials · Ophthalmic device
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Mar 1980
Decision
42d
Days
Class 2
Risk

K800140 is an FDA 510(k) clearance for the SILASTIC SCLERAL SPONGE II W/CIRCLING BD. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dow Corning Corp. Healthcare Industries Materials devices

Submission Details

510(k) Number K800140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date March 03, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQX Implant, Orbital, Extra-ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3340
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.