Cleared Traditional

PERACT 20 LIQUID STERILANT (K960513) - FDA 510(k) Clearance

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

K960513 · Minntech Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
604d
Days
Class 2
Risk

K960513 is an FDA 510(k) clearance for the PERACT 20 LIQUID STERILANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 604 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Minntech Corp. devices

Submission Details

510(k) Number K960513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date October 01, 1997
Days to Decision 604 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
475d slower than avg
Panel avg: 129d · This submission: 604d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 63
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