Cleared Traditional

K953257 - ORALSENSOR

K953257 is an FDA 510(k) clearance for ORALSENSOR, manufactured by Cycura Corp.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K953257 · Cycura Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
230d
Days
Class 2
Risk

K953257 is an FDA 510(k) clearance for the ORALSENSOR. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Cycura Corp. (Rocklin, US). The FDA issued a Cleared decision on February 27, 1996 after a review of 230 days - an extended review cycle.

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 - K953257

510(k) Number K953257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date February 27, 1996
Days to Decision 230 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
81d slower than avg
Panel avg: 149d · This submission: 230d
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 143
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K953257.
SYNERGY PLUS
K960762 · The Prometheus Group · Jun 1996
AT53 DUAL CHANNEL EMG
K952797 · Stoelting Co. · Apr 1996
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co. · Mar 1996
BIOFEEDBACK DEVICE
K954127 · Verimed Holdings, Inc. · Nov 1995
RELAXPLUS
K951213 · Ultramind International , Ltd. · Sep 1995
A620 EEG
K944615 · Stoelting Co. · Sep 1995
K953257 · ORALSENSOR
Download PDF FDA Summary Cycura Corp.