Cleared Traditional

K813489 - ROCKING/CIRCULATING CYTO-THERM II 3570

K813489 is an FDA 510(k) clearance for ROCKING/CIRCULATING CYTO-THERM II 3570, manufactured by Cryosan, Inc.. The device is a Class 2 Hematology device with product code KZL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K813489

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.

KZL Device Classification - Class 2, Special Controls

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.