Cleared Traditional

K890754 - SPORVIEW CULTURE MEDIA

K890754 is the FDA 510(k) clearance for SPORVIEW CULTURE MEDIA by Spsmedical Supply Corp.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K890754 · Spsmedical Supply Corp. · General Hospital
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Nov 1989
Decision
276d
Days
Class 2
Risk

K890754 is an FDA 510(k) clearance for the SPORVIEW CULTURE MEDIA. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rochester, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 276 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 Spsmedical Supply Corp. devices

Submission Details

510(k) Number K890754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date November 17, 1989
Days to Decision 276 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 129d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 123
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K890754.
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · Parke-Davis Co. · Nov 1985