Cleared Traditional

K883320 - MONOJECT TRACE ELEMENT BLOOD COLLECTION...

K883320 is the FDA 510(k) clearance for MONOJECT TRACE ELEMENT BLOOD COLLECTION... by Sherwood Medical Co.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K883320 · Sherwood Medical Co. · Chemistry device
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Sep 1988
Decision
53d
Days
Class 2
Risk

K883320 is an FDA 510(k) clearance for the MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on September 27, 1988 after a review of 53 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K883320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1988
Decision Date September 27, 1988
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K883320.
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · Ciba Corning Diagnostics Corp. · Nov 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · Sherwood Medical Co. · Aug 1988
HR VACUTRAC
K881201 · Icu Medical, Inc. · May 1988
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · Dynatech Laboratories, Inc. · Jan 1987