Cleared Traditional

K020399 - RESPERATE

Also marketed or referenced as:
MODEL RR-150

K020399 is an FDA 510(k) clearance for RESPERATE, manufactured by Intercure , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K020399 · Intercure , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
146d
Days
Class 2
Risk

K020399 is an FDA 510(k) clearance for the RESPERATE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Intercure , Ltd. (Washington, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intercure , Ltd. devices

FDA 510(k) Submission Details - K020399

510(k) Number K020399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2002
Decision Date July 02, 2002
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 148d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 53
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K020399.
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SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
NEUROCOMP
K993654 · Neurocybernetics · Jan 2000