Cleared Traditional

K830836 - Q.C. TESTER

K830836 is the FDA 510(k) clearance for Q.C. TESTER by Alltek Filtration, Inc.. It is a Class 2 Microbiology device (product code LHI) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K830836 · Alltek Filtration, Inc. · Microbiology device
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Apr 1983
Decision
27d
Days
Class 2
Risk

K830836 is an FDA 510(k) clearance for the Q.C. TESTER. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Alltek Filtration, Inc. (Walker, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 880.5440 - 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 Alltek Filtration, Inc. devices

Submission Details

510(k) Number K830836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1983
Decision Date April 18, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K830836.
VIAL VENT FILTER
K852467 · Baxter Healthcare Corp · Oct 1985
TRANSFER DEVICE
K853188 · Advance Medical Designs, Inc. · Aug 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · Travenol Laboratories, S.A. · Jan 1985
ACKRAD FLUID CONNECTING SET
K820937 · Ackrad Laboratories · Apr 1982
VACU-FIL TRANSFER SET
K812928 · American Pharmaseal Div. Ahsc · Dec 1981