Cleared Traditional

K881105 - CULTURE COLLECTION DEVICE

K881105 is the FDA 510(k) clearance for CULTURE COLLECTION DEVICE by Medical Packaging Corp.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K881105 · Medical Packaging Corp. · Microbiology device
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Apr 1988
Decision
41d
Days
Class 1
Risk

K881105 is an FDA 510(k) clearance for the CULTURE COLLECTION DEVICE. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medical Packaging Corp. (Camarillo, US). The FDA issued a Cleared decision on April 25, 1988 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Medical Packaging Corp. devices

Submission Details

510(k) Number K881105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date April 25, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K881105.
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · Acumedia Manufacturers, Inc. · Apr 1988
AMIES TRANSPORT MEDIUM
K881539 · Acumedia Manufacturers, Inc. · Apr 1988
STUARTS TRANSPORT MEDIUM
K881569 · Acumedia Manufacturers, Inc. · Apr 1988