Cleared Traditional

K822624 - O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381

K822624 is an FDA 510(k) clearance for O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381, manufactured by Del Mar Avionics. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K822624 · Del Mar Avionics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
37d
Days
Class 2
Risk

K822624 is an FDA 510(k) clearance for the O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Del Mar Avionics (Walker, US). The FDA issued a Cleared decision on October 6, 1982 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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: 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K822624

510(k) Number K822624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1982
Decision Date October 06, 1982
Days to Decision 37 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 148d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 39
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K822624.
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