Cleared Traditional

K833475 - CAPIJECT SYS CAPILLARY BLOOD COLLECT

K833475 is an FDA 510(k) clearance for CAPIJECT SYS CAPILLARY BLOOD COLLECT, manufactured by Terumo Medical Corp.. The device is a Class 2 Toxicology device with product code JKA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K833475 · Terumo Medical Corp. · Toxicology device
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Dec 1983
Decision
63d
Days
Class 2
Risk

K833475 is an FDA 510(k) clearance for the CAPIJECT SYS CAPILLARY BLOOD COLLECT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Walker, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K833475

510(k) Number K833475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1983
Decision Date December 08, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 122
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K833475.
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
MONOJET SPS BLOOD COLLECTION TUBE
K831719 · Sherwood Medical Co. · Jul 1983
LIPOSOL
K830472 · Quest Medical, Inc. · Jun 1983
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
K831242 · American Dade · May 1983