Cleared Traditional

K801518 - SPAN-AID BRIDGING PILLOW SYSTEM

K801518 is the FDA 510(k) clearance for SPAN-AID BRIDGING PILLOW SYSTEM by Span-America Medical Systems, Inc.. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801518 · Span-America Medical Systems, Inc. · Ophthalmic device
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Aug 1980
Decision
34d
Days
Class 2
Risk

K801518 is an FDA 510(k) clearance for the SPAN-AID BRIDGING PILLOW SYSTEM. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Span-America Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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 Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K801518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1980
Decision Date August 04, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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.