Cleared Traditional

ROCKING/CIRCULATING CYTO-THERM II 3570 (K813489) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813489 · Cryosan, Inc. · Hematology device
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Mar 1982
Decision
93d
Days
Class 2
Risk

K813489 is an FDA 510(k) clearance for the ROCKING/CIRCULATING CYTO-THERM II 3570. Classified as Device, Warming. Blood And Plasma (product code KZL), Class II - Special Controls.

Submitted by Cryosan, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryosan, Inc. devices

Submission Details

510(k) Number K813489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date March 04, 1982
Days to Decision 93 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KZL Device, Warming. Blood And Plasma
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9205
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 Hematology devices follow this clearance model.