Cleared Traditional

K831242 - LITHIUM HEPARINIZED BLOOD COLLECT-TUBE

K831242 is the FDA 510(k) clearance for LITHIUM HEPARINIZED BLOOD COLLECT-TUBE by American Dade. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K831242 · American Dade · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
31d
Days
Class 2
Risk

K831242 is an FDA 510(k) clearance for the LITHIUM HEPARINIZED BLOOD COLLECT-TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 31 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 American Dade devices

Submission Details

510(k) Number K831242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 16, 1983
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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 K831242.
CAPIJECT SYS CAPILLARY BLOOD COLLECT
K833475 · Terumo Medical Corp. · Dec 1983
MONOJET SPS BLOOD COLLECTION TUBE
K831719 · Sherwood Medical Co. · Jul 1983
LIPOSOL
K830472 · Quest Medical, Inc. · Jun 1983
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL
K823836 · Sherwood Medical Co. · Jan 1983
MONOJECT SAMPLETTE CAPILLARY SERUM SEP
K823176 · Sherwood Medical Co. · Nov 1982
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · Sherwood Medical Co. · Apr 1982