Cleared Traditional

K931417 - STERILE EQUIPMENT COVERS (FDA 510(k) Clearance)

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

K931417 · Custom Medical Products, Ltd. · General Hospital
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Jul 1995
Decision
836d
Days
Class 2
Risk

K931417 is an FDA 510(k) clearance for the STERILE EQUIPMENT COVERS. Classified as Cover, Barrier, Protective (product code MMP), Class II - Special Controls.

Submitted by Custom Medical Products, Ltd. (Great Neck, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 836 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Custom Medical Products, Ltd. devices

Submission Details

510(k) Number K931417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date July 06, 1995
Days to Decision 836 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
708d slower than avg
Panel avg: 128d · This submission: 836d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMP Cover, Barrier, Protective
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.