Cleared Traditional

K961721 - STERITEC DISPOSABLE BIOLOGICAL TEST PACK

K961721 is an FDA 510(k) clearance for STERITEC DISPOSABLE BIOLOGICAL TEST PACK, manufactured by Steritec Products Mfg Co, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K961721 · Steritec Products Mfg Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
112d
Days
Class 2
Risk

K961721 is an FDA 510(k) clearance for the STERITEC DISPOSABLE BIOLOGICAL TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on August 23, 1996 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Steritec Products Mfg Co, Inc. devices

FDA 510(k) Submission Details - K961721

510(k) Number K961721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1996
Decision Date August 23, 1996
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K961721.
EZTEST-GAS
K930683 · Sgm Biomedical, Inc. · Mar 1997
EZTEST
K963841 · Sgm Biotech, Inc. · Feb 1997
PROSPORE(STEARO FOR STEAM STERILIZER)
K962441 · Raven Biological Laboratories, Inc. · Sep 1996
PROSPORE II
K960790 · Raven Biological Laboratories, Inc. · Aug 1996
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
K960777 · Mdt Corp., Inc. · May 1996
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995