Cleared Traditional

DELTATALKER WITH INFRARED (K961306) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961306 · Prentke Romich Co. · Physical Medicine device
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Jun 1996
Decision
84d
Days
Class 2
Risk

K961306 is an FDA 510(k) clearance for the DELTATALKER WITH INFRARED. Classified as System, Environmental Control, Powered (product code IQA), Class II - Special Controls.

Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3725 - 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.

View all Prentke Romich Co. devices

Submission Details

510(k) Number K961306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date June 27, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IQA System, Environmental Control, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3725
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 Physical Medicine devices follow this clearance model.