Cleared Traditional

SHAVE PREP KITS (K842989) - FDA 510(k) Clearance

Class I General Hospital device.

K842989 · Biological & Environmental Control Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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.

Regulatory Peers - KME Bedding, Disposable, Medical

All 9
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K842989.
DEPEND UNDERPAD
K870522 · Kimberly-Clark Corp. · Mar 1987
KIMLON DISPOSABLE BLANKET
K863179 · Kimberly-Clark Corp. · Aug 1986
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978
TOWELS, SHEETS, PILLOWCASES
K781227 · Abco Dealers, Inc. · Oct 1978