Cleared Traditional

K842989 - SHAVE PREP KITS

K842989 is an FDA 510(k) clearance for SHAVE PREP KITS, 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 127-day FDA review.

K842989 · Biological & Environmental Control Laboratories · General Hospital
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Dec 1984
Decision
127d
Days
Class 1
Risk

K842989 is an FDA 510(k) clearance for the SHAVE PREP KITS. 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 127 days - within the typical 510(k) review window.

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: 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 Biological & Environmental Control Laboratories devices

FDA 510(k) Submission Details - K842989

510(k) Number K842989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date December 04, 1984
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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 K842989.
SINGLE-USE PATIENT UNDERPAD
K862348 · Procter & Gamble Mfg. Co. · Jul 1986
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · 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