Cleared Traditional

K872058 - ORICULT-N CULTURE-PADDLE

K872058 is an FDA 510(k) clearance for ORICULT-N CULTURE-PADDLE, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K872058 · Orion Corp. · Microbiology device
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Jun 1987
Decision
13d
Days
Class 1
Risk

K872058 is an FDA 510(k) clearance for the ORICULT-N CULTURE-PADDLE. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on June 10, 1987 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Orion Corp. devices

FDA 510(k) Submission Details - K872058

510(k) Number K872058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date June 10, 1987
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 231
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K872058.
IAFP BILE ESCULIN AGAR
K872683 · I.A.F. Production, Inc. · Aug 1987
SORBITOL MACCONKEY AGAR NO. 3 CM 813
K872956 · Oxoid U.S.A., Inc. · Aug 1987
MACCONKEY W/SORBITOL
K872188 · Remel Co. · Jun 1987
BACTEROIDES BILE ESCULIN AGAR
K870638 · Hardy Media · Apr 1987
CETRIMIDE SELECTIVE AGAR
K870640 · Hardy Media · Apr 1987
POTATO DEXTROSE AGAR
K870643 · Hardy Media · Apr 1987