Cleared Traditional

K960777 - MDT UNISPORE AND SPOR-TEST BIOLOGICALIN...

K960777 is an FDA 510(k) clearance for MDT UNISPORE AND SPOR-TEST BIOLOGICALIN..., manufactured by Mdt Corp., Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K960777 · Mdt Corp., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
87d
Days
Class 2
Risk

K960777 is an FDA 510(k) clearance for the MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 87 days - a notably fast clearance cycle.

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: 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 Mdt Corp., Inc. devices

FDA 510(k) Submission Details - K960777

510(k) Number K960777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1996
Decision Date May 23, 1996
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 124
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K960777.
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · Advanced Sterilization Products · Feb 2002
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992