Cleared Traditional

K860066 - REFLECTIVE BLANKET

K860066 is an FDA 510(k) clearance for REFLECTIVE BLANKET, manufactured by O.R. Concepts, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K860066 · O.R. Concepts, Inc. · General Hospital
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Feb 1986
Decision
44d
Days
Class 1
Risk

K860066 is an FDA 510(k) clearance for the REFLECTIVE BLANKET. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by O.R. Concepts, Inc. (Irving, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 44 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K860066

510(k) Number K860066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 19, 1986
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 25
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K860066.
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
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
SHAVE PREP KITS
K842989 · Biological & Environmental Control Laboratories · Dec 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · Biological & Environmental Control Laboratories · Dec 1984