Cleared Traditional

K925754 - ECONOM

K925754 is an FDA 510(k) clearance for ECONOM, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 1 General & Plastic Surgery device with product code EPY cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K925754 · Rudolf Riester GmbH & Co. KG · General & Plastic Surgery device
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Oct 1993
Decision
329d
Days
Class 1
Risk

K925754 is an FDA 510(k) clearance for the ECONOM. Classified as Speculum, Ent (product code EPY), Class I - General Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on October 8, 1993 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1800 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K925754

510(k) Number K925754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date October 08, 1993
Days to Decision 329 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 115d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

EPY Device Classification - Class 1, General Controls

Product Code EPY Speculum, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.1800
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 - EPY Speculum, Ent

All 10
Devices cleared under the same product code (EPY) and FDA review panel - the closest regulatory comparables to K925754.
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