Cleared Traditional

DISPOSA-LOOPS (K780548) - FDA 510(k) Clearance

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

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.

View all Medi-Spec devices

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 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780548.
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · Avery Dennison Medical , Ltd. · Oct 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005