Cleared Traditional

K894980 - BIO-CAL 370 HEATER/COOLER

K894980 is an FDA 510(k) clearance for BIO-CAL 370 HEATER/COOLER, manufactured by Bio Medicus, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K894980 · Bio Medicus, Inc. · Cardiovascular device
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Nov 1989
Decision
86d
Days
Class 2
Risk

K894980 is an FDA 510(k) clearance for the BIO-CAL 370 HEATER/COOLER. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 2, 1989 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. 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 Bio Medicus, Inc. devices

FDA 510(k) Submission Details - K894980

510(k) Number K894980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date November 02, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 111
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K894980.
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