Cleared Traditional

K881201 - HR VACUTRAC

K881201 is the FDA 510(k) clearance for HR VACUTRAC by Icu Medical, Inc.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K881201 · Icu Medical, Inc. · Chemistry device
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May 1988
Decision
56d
Days
Class 2
Risk

K881201 is an FDA 510(k) clearance for the HR VACUTRAC. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on May 16, 1988 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K881201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date May 16, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 Chemistry 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 K881201.
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · Ciba Corning Diagnostics Corp. · Nov 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · Sherwood Medical Co. · Sep 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · Sherwood Medical Co. · Aug 1988
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · Dynatech Laboratories, Inc. · Jan 1987
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
K853152 · Sherwood Medical Co. · Aug 1985
ISOSTAT MICROBIAL TUBE PROCESSING
K840496 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984