Cleared Traditional

K830645 - BLEEDING TIME DEVICE DISPOSABLE

K830645 is an FDA 510(k) clearance for BLEEDING TIME DEVICE DISPOSABLE, manufactured by American Dade. The device is a Class 2 Hematology device with product code JCA cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K830645 · American Dade · Hematology device
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Mar 1983
Decision
16d
Days
Class 2
Risk

K830645 is an FDA 510(k) clearance for the BLEEDING TIME DEVICE DISPOSABLE. Classified as Device, Bleeding Time (product code JCA), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 16 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 American Dade devices

FDA 510(k) Submission Details - K830645

510(k) Number K830645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date March 17, 1983
Days to Decision 16 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
97d faster than avg
Panel avg: 113d · This submission: 16d
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 K830645.
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · International Technidyne Corp. · Jul 1991
Q.I.C. BLEEDING TIME DEVICE
K871318 · Helena Laboratories · Jun 1987
SURGICUTT - BLEEDING TIME DEVICE
K850542 · International Technidyne Corp. · Mar 1985
AUTOLET
K801815 · Ulster Scientific, Inc. · Oct 1980
SIMPLATE
K761250 · General Diagnostics · Mar 1977