Cleared Traditional

K850717 - AMIES TRANSPORT MEDIA

K850717 is the FDA 510(k) clearance for AMIES TRANSPORT MEDIA by Rapid City Regional Hospital, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850717 · Rapid City Regional Hospital, Inc. · Microbiology device
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Mar 1985
Decision
28d
Days
Class 1
Risk

K850717 is an FDA 510(k) clearance for the AMIES TRANSPORT MEDIA. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Rapid City Regional Hospital, Inc. (Rapid City, US). The FDA issued a Cleared decision on March 22, 1985 after a review of 28 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 Rapid City Regional Hospital, Inc. devices

Submission Details

510(k) Number K850717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date March 22, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
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 K850717.
TRANSPORT CULTURE MEDIA
K854715 · Hillcrest Biologicals · Dec 1985
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
K854061 · Syva Co. · Oct 1985
ORTHO VIRAL TRANSPORT
K853500 · Ortho Diagnostic Systems, Inc. · Aug 1985
CHLAMYDIAL TRANSPORT MEDIA
K850124 · Hillcrest Biologicals · Mar 1985
VIRAL TRANSPORT MEDIA
K844747 · Hillcrest Biologicals · Jan 1985
CHLAMYDIAL TRANSPORT MEDIUM
K834125 · Bartels Immunodiagnostic Supplies, Inc. · Feb 1984