Cleared Traditional

K896794 - SPECIMEN CONTAINER

K896794 is the FDA 510(k) clearance for SPECIMEN CONTAINER by Westmark, Sterile Packing Systems, Inc. (Sps). It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896794 · Westmark, Sterile Packing Systems, Inc. (Sps) · Microbiology device
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Mar 1990
Decision
90d
Days
Class 1
Risk

K896794 is an FDA 510(k) clearance for the SPECIMEN CONTAINER. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Westmark, Sterile Packing Systems, Inc. (Sps) devices

Submission Details

510(k) Number K896794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date March 01, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIO Device, Specimen Collection

All 12
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K896794.
PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987