Cleared Traditional

K841709 - 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP

K841709 is an FDA 510(k) clearance for 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP, manufactured by Skyland Scientific Services, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K841709 · Skyland Scientific Services, Inc. · General Hospital
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Oct 1984
Decision
162d
Days
Class 2
Risk

K841709 is an FDA 510(k) clearance for the 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Skyland Scientific Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984 after a review of 162 days - an extended review 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: 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 Skyland Scientific Services, Inc. devices

FDA 510(k) Submission Details - K841709

510(k) Number K841709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date October 02, 1984
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
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 185
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K841709.
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · Parke-Davis Co. · Nov 1985
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
K850144 · American Sterilizer Co. · Jun 1985
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · Travenol Laboratories, S.A. · Nov 1983
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · Sybron Corp. · Sep 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981