CIRCULATING CYTO-THERMS— 510(k) K812311

Name: FDA 510(k) clearance K812311
Creator: U.S. Food and Drug Administration
Published: 1981-09-16

Substantially Equivalent

Cryosan, Inc.

FDA 510(k) clearance K812311 for CIRCULATING CYTO-THERMS, Substantially Equivalent on 1981-09-16. Applicant: Cryosan, Inc.. Device class: 2.

Clearance details

Applicant: Cryosan, Inc.
Product code: Code KZL
Device class: Class 2
Regulation: 21 CFR 864.9205
Advisory panel: Hematology
Date received: 1981-08-17
Decision date: 1981-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZL

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K813489 — ROCKING/CIRCULATING CYTO-THERM II 35701982-03-04
K800699 — FLO TEM (FLUID WARNER)1980-05-08
K790936 — MODEL 114 TREONIC H150 HAEMOHEATER1979-09-04

More clearances from Cryosan, Inc.

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K831953 — INFUSION PUMP1983-07-19
K830831 — AUTOMATED BLOOD CELL SEPARATOR1983-06-16
K822521 — AUTOMATED BLOOD CELL SEPARATOR1982-09-30
K812309 — CRYOSAN NORMAL SALINE1981-09-16

Adverse events under product code KZL

product code KZL

Death: 3
Malfunction: 473
Total: 476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.