Cleared Traditional

K871318 - Q.I.C. BLEEDING TIME DEVICE

K871318 is an FDA 510(k) clearance for Q.I.C. BLEEDING TIME DEVICE, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JCA cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K871318 · Helena Laboratories · Hematology device
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Jun 1987
Decision
68d
Days
Class 2
Risk

K871318 is an FDA 510(k) clearance for the Q.I.C. BLEEDING TIME DEVICE. Classified as Device, Bleeding Time (product code JCA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 10, 1987 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6100 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K871318

510(k) Number K871318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1987
Decision Date June 10, 1987
Days to Decision 68 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
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCA Device Classification - Class 2, Special Controls

Product Code JCA Device, Bleeding Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6100
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 - JCA Device, Bleeding Time

Devices cleared under the same product code (JCA) and FDA review panel - the closest regulatory comparables to K871318.
SIMPLATE PEDIATRIC
K911745 · Organon Teknika Corp. · Aug 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · International Technidyne Corp. · Jul 1991
SURGICUTT - BLEEDING TIME DEVICE
K850542 · International Technidyne Corp. · Mar 1985
BLEEDING TIME DEVICE DISPOSABLE
K830645 · American Dade · Mar 1983
AUTOLET
K801815 · Ulster Scientific, Inc. · Oct 1980
SIMPLATE
K761250 · General Diagnostics · Mar 1977