Cleared Traditional

K844196 - WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT

K844196 is an FDA 510(k) clearance for WET SKIN SCRUB TRAY STERILE WET SKIN SC..., manufactured by Biological & Environmental Control Laboratories. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 35-day FDA review.

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

FDA 510(k) Submission Details - K844196

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

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.

Regulatory Peers - KME Bedding, Disposable, Medical

All 24
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K844196.
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
SHAVE PREP KITS
K842989 · Biological & Environmental Control Laboratories · Dec 1984
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
PILLOW COVER, ANTI-MICROBIAL
K832486 · American Threshold Industries, Inc. · Feb 1984
DRAW SHEET, ANTI-MICROBIAL
K832487 · American Threshold Industries, Inc. · Feb 1984