Cleared Traditional

K883989 - KVM ISOTONIC FLUSH SOLUTION

K883989 is the FDA 510(k) clearance for KVM ISOTONIC FLUSH SOLUTION by Kvm Technologies, Inc.. It is a Class 1 Hematology device (product code GIF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K883989 · Kvm Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
22d
Days
Class 1
Risk

K883989 is an FDA 510(k) clearance for the KVM ISOTONIC FLUSH SOLUTION. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Kvm Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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 Kvm Technologies, Inc. devices

Submission Details

510(k) Number K883989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date October 12, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GIF Diluent, Blood Cell

All 10
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K883989.
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · R&D Systems, Inc. · Jul 1988
HAYEM DILUTING FLUID
K842929 · E K Ind., Inc. · Sep 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477 · Emd Chemicals, Inc. · Mar 1984
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · Fisher Scientific Co., LLC · Jun 1982
MODIFIED BLOOD CELL COUNTING & LYSING
K801357 · Coulter Electronics, Inc. · Aug 1980
ISOTONIC DILUENT
K781008 · Mallinckrodt Critical Care · Jun 1978