Cleared Traditional

K810664 - ISOLATOR SYSTEM

K810664 is the FDA 510(k) clearance for ISOLATOR SYSTEM by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810664 · E.I. Dupont DE Nemours & Co., Inc. · Hematology device
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Mar 1981
Decision
20d
Days
Class 2
Risk

K810664 is an FDA 510(k) clearance for the ISOLATOR SYSTEM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K810664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1981
Decision Date March 31, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 113d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K810664.
MONOJECT SAMPLETTE CAPILLARY SERUM SEP
K823176 · Sherwood Medical Co. · Nov 1982
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · Sherwood Medical Co. · Apr 1982
MONOJECT STERILE CORVAC BLOOD TUBE
K812285 · Sherwood Medical Co. · Aug 1981
BLOOD FLUID FILTERS
K792723 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1980
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · Hoffmann-La Roche, Inc. · May 1979