Cleared Traditional

K894170 - DEVON DISPOSABLE HEAD POSITIONER COVER

K894170 is an FDA 510(k) clearance for DEVON DISPOSABLE HEAD POSITIONER COVER, manufactured by Devon Industries, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894170 · Devon Industries, Inc. · General Hospital
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Sep 1989
Decision
84d
Days
Class 1
Risk

K894170 is an FDA 510(k) clearance for the DEVON DISPOSABLE HEAD POSITIONER COVER. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on September 7, 1989 after a review of 84 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K894170

510(k) Number K894170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1989
Decision Date September 07, 1989
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 17
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K894170.
RECEIVING BLANKET
K904274 · Anago, Inc. · Oct 1990
DEPEND UNDERPAD
K870522 · Kimberly-Clark Corp. · Mar 1987
KIMLON DISPOSABLE BLANKET
K863179 · Kimberly-Clark Corp. · Aug 1986
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