Cleared Traditional

K112547 - NEO NEST

K112547 is an FDA 510(k) clearance for NEO NEST, manufactured by Denovo Proucts, LLC. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K112547 · Denovo Proucts, LLC · Physical Medicine device
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Mar 2012
Decision
187d
Days
Class 1
Risk

K112547 is an FDA 510(k) clearance for the NEO NEST. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Denovo Proucts, LLC (Ft. Myers, US). The FDA issued a Cleared decision on March 6, 2012 after a review of 187 days - an extended review cycle.

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 - K112547

510(k) Number K112547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date March 06, 2012
Days to Decision 187 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 116d · This submission: 187d
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 K112547.
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K163295 · Rapid Aid Corp. · Jul 2017
EYEFEEL OPHTHALMIC WARMER
K082087 · Bio-Lipid, Inc. · Sep 2008
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K071710 · Johnson & Johnson Consumer Products, Inc. · Aug 2007
EYEFEEL OPHTHALMIC WARMER
K021843 · Bio-Lipid, Inc. · Sep 2002
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · Allegiance Healthcare Corp. · Jan 1999
K112547 · NEO NEST
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