Cleared Traditional

K930313 - APEX SPECIMEN BAG

K930313 is the FDA 510(k) clearance for APEX SPECIMEN BAG by Apex Medical Technologies, Inc.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K930313 · Apex Medical Technologies, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
55d
Days
Class 1
Risk

K930313 is an FDA 510(k) clearance for the APEX SPECIMEN BAG. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Apex Medical Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apex Medical Technologies, Inc. devices

Submission Details

510(k) Number K930313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date March 18, 1993
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 102d · This submission: 55d
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 14
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K930313.
BACTI-SWAB DRY
K013711 · Remel Co. · Nov 2001
ZINC PVA
K931383 · Remel Co. · Jun 1993
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