Cleared Traditional

K914780 - TALLEY SD.500 SKIN PRESSURE EVALUATOR

K914780 is an FDA 510(k) clearance for TALLEY SD.500 SKIN PRESSURE EVALUATOR, manufactured by Talley Group, Ltd.. The device is a Class 1 Physical Medicine device with product code IKE cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K914780 · Talley Group, Ltd. · Physical Medicine device
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Dec 1991
Decision
57d
Days
Class 1
Risk

K914780 is an FDA 510(k) clearance for the TALLEY SD.500 SKIN PRESSURE EVALUATOR. Classified as Transducer, Miniature Pressure (product code IKE), 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 890.1615 - 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 - K914780

510(k) Number K914780 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.

IKE Device Classification - Class 1, General Controls

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
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 - IKE Transducer, Miniature Pressure

All 14
Devices cleared under the same product code (IKE) and FDA review panel - the closest regulatory comparables to K914780.
PORTABLE LIMB LOAD MONITOR (BMLLM-100)
K915326 · Bar Med Pty , Ltd. · Oct 1992
IOWA ORAL PERFORMANCE ISNTRUMENT
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FPL
K915897 · Wrm Computers · Apr 1992
MICRO-EMED-SYSTEM
K902967 · Novel Electronics, Inc. · Sep 1990
DYNATRON 2000
K880912 · Dynatronics Corp. · Mar 1988
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1
K875103 · Shield Computers , Ltd. · Jan 1988
K914780 · TALLEY SD.500 SKIN PRESSURE EVALUATOR
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