Cleared Traditional

BANDAGE, COMPRESSION, FISTULAID (K781110) - FDA 510(k) Clearance

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

K781110 · Medical Device Laboratories · Toxicology device
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Aug 1978
Decision
46d
Days
Class 2
Risk

K781110 is an FDA 510(k) clearance for the BANDAGE, COMPRESSION, FISTULAID. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Medical Device Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 18, 1978 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - the FDA toxicology 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.

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Submission Details

510(k) Number K781110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 18, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJC Thin Layer Chromatography, Methamphetamine

All 30
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