Cleared Traditional

K831325 - NUTROMAT

K831325 is an FDA 510(k) clearance for NUTROMAT, manufactured by Medlog GmbH Marketing Services. The device is a Class 1 General & Plastic Surgery device with product code GBB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831325 · Medlog GmbH Marketing Services · General & Plastic Surgery device
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Jun 1983
Decision
38d
Days
Class 1
Risk

K831325 is an FDA 510(k) clearance for the NUTROMAT. Classified as Chair, Surgical, Ac-powered (product code GBB), Class I - General Controls.

Submitted by Medlog GmbH Marketing Services (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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 Medlog GmbH Marketing Services devices

FDA 510(k) Submission Details - K831325

510(k) Number K831325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date June 02, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

GBB Device Classification - Class 1, General Controls

Product Code GBB Chair, Surgical, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - GBB Chair, Surgical, Ac-powered

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