Cleared Traditional

K780548 - DISPOSA-LOOPS

K780548 is the FDA 510(k) clearance for DISPOSA-LOOPS by Medi-Spec. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K780548 · Medi-Spec · General Hospital
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Aug 1978
Decision
138d
Days
Class 2
Risk

K780548 is an FDA 510(k) clearance for the DISPOSA-LOOPS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medi-Spec (Mchenry, US). The FDA issued a Cleared decision on August 21, 1978 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K780548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1978
Decision Date August 21, 1978
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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 K780548.
STOCKINETTE, DISPOSABLESURGICAL
K782091 · Anago, Inc. · Jan 1979
STOCKINETTE
K781944 · Kimberly-Clark Corp. · Dec 1978
U-DRAPE, BOUNDARY
K781172 · Procter & Gamble Mfg. Co. · Aug 1978
MAGNETIC DRAPE - INSTRUMENT HOLDER
K780865 · Devon Industries, Inc. · Aug 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839 · Surgikos, Inc. · Aug 1978
BARRIER LAPAROTOMY SHEET 450
K780840 · Surgikos, Inc. · Aug 1978