Cleared Traditional

K896794 - SPECIMEN CONTAINER

K896794 is an FDA 510(k) clearance for SPECIMEN CONTAINER, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K896794

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

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 28
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K896794.
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · Medical Laboratory Automation Systems, Inc. · Jan 1991
CHLAMYDIA ACCU-CULSHURE TM
K903405 · Medical Laboratory Automation Systems, Inc. · Oct 1990
VIRAL ACCU-CULSHURE TM
K903406 · Medical Laboratory Automation Systems, Inc. · Oct 1990
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988