Cleared Traditional

K770405 - OVERLOAD WARNING DEVICE (FDA 510(k) Clearance)

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

K770405 · Synthes (Usa) · Physical Medicine device
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770405 is an FDA 510(k) clearance for the OVERLOAD WARNING DEVICE. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Synthes (Usa) (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K770405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1977
Decision Date March 10, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRN Device, Warning, Overload, External Limb, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5575
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.