Cleared Traditional

K802790 - SOLVALINE

K802790 is an FDA 510(k) clearance for SOLVALINE, manufactured by Secol Co.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K802790 · Secol Co. · General Hospital
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Feb 1981
Decision
101d
Days
Class 2
Risk

K802790 is an FDA 510(k) clearance for the SOLVALINE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Secol Co. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1981 after a review of 101 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 Secol Co. devices

FDA 510(k) Submission Details - K802790

510(k) Number K802790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date February 13, 1981
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

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 218
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K802790.
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981
BACTERICIDAL INCISE DRAPE
K811871 · Surgikos, Inc. · Aug 1981
GATOR DRAPES
K811996 · The Anspach Effort, Inc. · Aug 1981
DISPOSABLE STERILE LAP SPONGE
K802980 · Anago, Inc. · Dec 1980
METALLINE DRESSINGS
K802787 · Secol Co. · Dec 1980
O.R. DRAPES
K802797 · Secol Co. · Dec 1980