Cleared Traditional

K934066 - NEPHRETECT

K934066 is an FDA 510(k) clearance for NEPHRETECT, manufactured by Alden Scientific, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 620-day FDA review.

K934066 · Alden Scientific, Inc. · General Hospital
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May 1995
Decision
620d
Days
Class 2
Risk

K934066 is an FDA 510(k) clearance for the NEPHRETECT. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Alden Scientific, Inc. (Winthrop, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 620 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Alden Scientific, Inc. devices

FDA 510(k) Submission Details - K934066

510(k) Number K934066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1993
Decision Date May 02, 1995
Days to Decision 620 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
491d slower than avg
Panel avg: 129d · This submission: 620d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 207
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K934066.
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K932129 · 3M Company · Mar 1994