Cleared Traditional

K801068 - STERILE ABDOMINAL PAD

K801068 is the FDA 510(k) clearance for STERILE ABDOMINAL PAD by Medspec Corp.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K801068 · Medspec Corp. · General Hospital
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May 1980
Decision
14d
Days
Class 2
Risk

K801068 is an FDA 510(k) clearance for the STERILE ABDOMINAL PAD. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medspec Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 14 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.

View all Medspec Corp. devices

Submission Details

510(k) Number K801068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date May 20, 1980
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 75
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K801068.
BOUNDARY SINGLE-USE DRAPE
K802148 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY SINGLE-USE DRAPES
K802192 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY SINGLE-USE DRAPES
K802247 · Procter & Gamble Mfg. Co. · Sep 1980
BOUNDARY EXTREMITY DRAPE
K801132 · Procter & Gamble Mfg. Co. · May 1980
STERILIZATION PROCESS CHANGE BOUNDARY
K792621 · Procter & Gamble Mfg. Co. · Jan 1980
STERILIZATION PROCESS/ABSORBENT TOWEL
K792623 · Procter & Gamble Mfg. Co. · Jan 1980