Cleared Traditional

K823675 - FRONING GUIDANCE SYSTEM #TX-8200

K823675 is an FDA 510(k) clearance for FRONING GUIDANCE SYSTEM #TX-8200, manufactured by Today'S Machining & Design, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K823675 · Today'S Machining & Design, Inc. · Neurology device
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Jan 1983
Decision
29d
Days
Class 2
Risk

K823675 is an FDA 510(k) clearance for the FRONING GUIDANCE SYSTEM #TX-8200. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Today'S Machining & Design, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Today'S Machining & Design, Inc. devices

FDA 510(k) Submission Details - K823675

510(k) Number K823675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1982
Decision Date January 05, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 356
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K823675.
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · Diasonics, Inc. · Jul 1985
PMT VAXIOM STEREOTACTIC SYS #FX001
K831329 · Progress Mankind Technology · Jun 1983
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983
LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER
K812744 · Progress Mankind Technology · Dec 1981
DYONICS STEROTOXIC POSITIONER
K790502 · Dyonics, Inc. · Apr 1979