Cleared Traditional

K821332 - DUSTCOVERS &/OR STERILITY MAINT. COVERS

K821332 is an FDA 510(k) clearance for DUSTCOVERS &/OR STERILITY MAINT. COVERS, manufactured by Medical Industries Packaging, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821332 · Medical Industries Packaging, Inc. · General Hospital
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May 1982
Decision
23d
Days
Class 2
Risk

K821332 is an FDA 510(k) clearance for the DUSTCOVERS &/OR STERILITY MAINT. COVERS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Medical Industries Packaging, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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: 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 Medical Industries Packaging, Inc. devices

FDA 510(k) Submission Details - K821332

510(k) Number K821332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date May 27, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 245
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K821332.
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