Cleared Traditional

AUTOMATED BLOOD CELL SEPARATOR (K830831) - FDA 510(k) Clearance

K830831 · Cryosan, Inc. · Hematology device
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Jun 1983
Decision
92d
Days
-
Risk

K830831 is an FDA 510(k) clearance for the AUTOMATED BLOOD CELL SEPARATOR. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Cryosan, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 92 days - within the typical 510(k) review window.

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

View all Cryosan, Inc. devices

Submission Details

510(k) Number K830831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1983
Decision Date June 16, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
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 K830831.
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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