Cleared Traditional

K850544 - SHAVE PREP TRAY

K850544 is the FDA 510(k) clearance for SHAVE PREP TRAY by Packaging Technologies, Inc.. It is a Class 1 General Hospital device (product code KME) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850544 · Packaging Technologies, Inc. · General Hospital
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Mar 1985
Decision
28d
Days
Class 1
Risk

K850544 is an FDA 510(k) clearance for the SHAVE PREP TRAY. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Packaging Technologies, Inc. (Brea, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 28 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 Packaging Technologies, Inc. devices

Submission Details

510(k) Number K850544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1985
Decision Date March 12, 1985
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 18
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K850544.
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
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981