Cleared Traditional

K800490 - STERILE DRESSING PACK

K800490 is the FDA 510(k) clearance for STERILE DRESSING PACK by Medi-Spec. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K800490 · Medi-Spec · General Hospital
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Mar 1980
Decision
8d
Days
Class 2
Risk

K800490 is an FDA 510(k) clearance for the STERILE DRESSING PACK. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medi-Spec (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 8 days - a notably fast clearance cycle.

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: 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 K800490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date March 12, 1980
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
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.

Regulatory Peers - KKX Drape, Surgical

All 162
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K800490.
WHITE KNIGHT SUPPLEMENTAL DRAPE
K800928 · G.D. Searle and Co. · May 1980
BOUNDARY EXTREMITY DRAPE
K801132 · Procter & Gamble Mfg. Co. · May 1980
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
K800552 · Carl Zeiss, Inc. · Mar 1980
STERILIZATION PROCESS CHANGE BOUNDARY
K792621 · Procter & Gamble Mfg. Co. · Jan 1980
STERILIZATION PROCESS/ABSORBENT TOWEL
K792623 · Procter & Gamble Mfg. Co. · Jan 1980
INSTRUMENT PAD
K791864 · Procter & Gamble Mfg. Co. · Oct 1979