Cleared Traditional

K880302 - CALCIUM CHLORIDE SOLUTION 0.1M

K880302 is the FDA 510(k) clearance for CALCIUM CHLORIDE SOLUTION 0.1M by Hemotec, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K880302 · Hemotec, Inc. · Hematology device
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Feb 1988
Decision
25d
Days
Class 2
Risk

K880302 is an FDA 510(k) clearance for the CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: 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 Hemotec, Inc. devices

Submission Details

510(k) Number K880302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date February 19, 1988
Days to Decision 25 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.

Regulatory Peers - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K880302.
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · International Technidyne Corp. · Aug 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · International Technidyne Corp. · Aug 1988
VERIFY(R) REFERENCE PLASMA
K881348 · Organon Teknika Corp. · May 1988
CI-TROL COAGULATION CONTROLS II & III
K771346 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977