Cleared Traditional

K811358 - DEHYDRATED BILE

K811358 is the FDA 510(k) clearance for DEHYDRATED BILE by Acumedia Manufacturers, Inc.. It is a Class 2 Microbiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811358 · Acumedia Manufacturers, Inc. · Microbiology device
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May 1981
Decision
15d
Days
Class 2
Risk

K811358 is an FDA 510(k) clearance for the DEHYDRATED BILE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K811358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date May 29, 1981
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 589
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K811358.
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CT/T DATALINK-B7875 AA/B7875 AB
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SCANNER, COMPUTERIZED TOMOGRAPHIC
K803181 · General Electric Co. · Jan 1981
G.E. SCAN CAPABILITY CAT.#B7815F
K802045 · General Electric Co. · Oct 1980
SYNERVIEW MODEL 6545
K801407 · Philips Medical Systems (Cleveland), Inc. · Jul 1980