Cleared Traditional

K914776 - OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR

K914776 is an FDA 510(k) clearance for OXFORD PRESSURE MONITOR/TALLEY PRESSURE..., manufactured by Talley Group, Ltd.. The device is a Class 1 Physical Medicine device with product code JFC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K914776 · Talley Group, Ltd. · Physical Medicine device
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Dec 1991
Decision
57d
Days
Class 1
Risk

K914776 is an FDA 510(k) clearance for the OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Talley Group, Ltd. (Lansing, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K914776

510(k) Number K914776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date December 19, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 116d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

JFC Device Classification - Class 1, General Controls

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JFC System, Pressure Measurement, Intermittent

All 10
Devices cleared under the same product code (JFC) and FDA review panel - the closest regulatory comparables to K914776.
QA PRESSURE MEASUREMENT SYSTEM
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CDG GAIT ANALYSES SYSTEM
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MECHANICAL SHAPE SENSOR
K913510 · Pin Dot Products, Inc. · Sep 1991
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
K881284 · Nathaniel Gould Diagnostics, Inc. · Jul 1988
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
K882139 · Human Performance Technologies, Inc. · Jun 1988
K914776 · OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
Download PDF Talley Group, Ltd.