Cleared Traditional

K000405 - INTERCURE LTD. RESPI-LOW

K000405 is an FDA 510(k) clearance for INTERCURE LTD. RESPI-LOW, 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 100-day FDA review.

K000405 · Intercure , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
100d
Days
Class 2
Risk

K000405 is an FDA 510(k) clearance for the INTERCURE LTD. RESPI-LOW. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Intercure , Ltd. (Washington, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 100 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.

FDA 510(k) Submission Details - K000405

510(k) Number K000405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date May 17, 2000
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 149d · This submission: 100d
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 169
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K000405.
INSIGHT GENESIS
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REGAIN DESKTOP
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ORION PLATINUM
K003367 · Srs Medical Systems, Inc. · Jan 2001
NEUROCOMP
K993654 · Neurocybernetics · Jan 2000
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc. · Aug 1999
INSIGHT MILLENNIUM
K990778 · Fasstech · Jun 1999
K000405 · INTERCURE LTD. RESPI-LOW
Download PDF FDA Summary Intercure , Ltd.