Cleared Traditional

PLASMA DISCARD BAGS (K926409) - FDA 510(k) Clearance

K926409 · Apheresis Technologies, Inc. · Gastroenterology & Urology device
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Mar 1993
Decision
71d
Days
-
Risk

K926409 is an FDA 510(k) clearance for the PLASMA DISCARD BAGS. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Apheresis Technologies, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 2, 1993 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Apheresis Technologies, Inc. devices

Submission Details

510(k) Number K926409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date March 02, 1993
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

All 26
Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K926409.
AMICUS Separator System
K192150 · Fresenius Kabi AG · Nov 2019
Spectra Optia Apheresis System
K183081 · Terumobct, Inc. · Feb 2019
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
K180615 · Fresenius Kabi USA,Llc · Dec 2018
Spectra Optia Apheresis System
K181049 · Terumobct, Inc. · Nov 2018
Spectra Optia Apheresis System
K172590 · Terumobct, Inc. · Mar 2018