Cleared Traditional

K970694 - MODEL 1700, HYDRO PREP

K970694 is an FDA 510(k) clearance for MODEL 1700, manufactured by Physiometrix, Inc.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K970694 · Physiometrix, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
78d
Days
Class 2
Risk

K970694 is an FDA 510(k) clearance for the MODEL 1700, HYDRO PREP. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Physiometrix, Inc. (North Billerica, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Physiometrix, Inc. devices

FDA 510(k) Submission Details - K970694

510(k) Number K970694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date May 14, 1997
Days to Decision 78 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
71d faster than avg
Panel avg: 149d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 47
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K970694.
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