Cleared Traditional

K930313 - APEX SPECIMEN BAG

K930313 is an FDA 510(k) clearance for APEX SPECIMEN BAG, manufactured by Apex Medical Technologies, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K930313

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.

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 30
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K930313.
MID-STREAM COLLECTION SET-STERILE
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CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991