Cleared Traditional

K844196 - WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT (FDA 510(k) Clearance)

Class I General Hospital device.

K844196 · Biological & Environmental Control Laboratories · General Hospital
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Dec 1984
Decision
35d
Days
Class 1
Risk

K844196 is an FDA 510(k) clearance for the WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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 Biological & Environmental Control Laboratories devices

Submission Details

510(k) Number K844196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date December 04, 1984
Days to Decision 35 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
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.