Cleared Traditional

K021843 - EYEFEEL OPHTHALMIC WARMER

K021843 is an FDA 510(k) clearance for EYEFEEL OPHTHALMIC WARMER, manufactured by Bio-Lipid, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021843 · Bio-Lipid, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
90d
Days
Class 1
Risk

K021843 is an FDA 510(k) clearance for the EYEFEEL OPHTHALMIC WARMER. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Bio-Lipid, Inc. (Washington, US). The FDA issued a Cleared decision on September 3, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021843

510(k) Number K021843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2002
Decision Date September 03, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 54
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K021843.
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ALLEGIANCE PORTA-WARM MATTRESS
K982652 · Allegiance Healthcare Corp. · Jan 1999
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
K980509 · Deroyal Industries, Inc. · Feb 1998
CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
K974190 · Consolidated Products & Services, Inc. · Nov 1997
K021843 · EYEFEEL OPHTHALMIC WARMER
Download PDF FDA Summary Bio-Lipid, Inc.