Cleared Traditional

K851164 - DENTOCULT CULTURE-PADDLE

K851164 is an FDA 510(k) clearance for DENTOCULT CULTURE-PADDLE, manufactured by Orion Corp.. The device is a Class 1 Microbiology device with product code JJJ cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K851164 · Orion Corp. · Microbiology device
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Oct 1985
Decision
221d
Days
Class 1
Risk

K851164 is an FDA 510(k) clearance for the DENTOCULT CULTURE-PADDLE. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 29, 1985 after a review of 221 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orion Corp. devices

FDA 510(k) Submission Details - K851164

510(k) Number K851164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1985
Decision Date October 29, 1985
Days to Decision 221 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
119d slower than avg
Panel avg: 102d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 31
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K851164.
ABBOTT VERTEX ANALYZER
K920559 · Abbott Laboratories · Mar 1992
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · Lkb Instruments, Inc. · Nov 1987
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
K862206 · Micromedic Systems · Aug 1986
1208 BETACORD AND 1208 BETCORD M
K852434 · Lkb Instruments, Inc. · Aug 1985
MICROSTAT GAMMA COUNTER
K842902 · Micromedic Systems · Aug 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984