Cleared Traditional

K860306 - BT-795/P AUTOMATED AUTOTRANS

K860306 is the FDA 510(k) clearance for BT-795/P AUTOMATED AUTOTRANS by Electromedics, Inc.. It is a Class 2 Hematology device (product code CAC) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K860306 · Electromedics, Inc. · Hematology device
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Mar 1986
Decision
37d
Days
Class 2
Risk

K860306 is an FDA 510(k) clearance for the BT-795/P AUTOMATED AUTOTRANS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 868.5830 - 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 Electromedics, Inc. devices

Submission Details

510(k) Number K860306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date March 06, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 113d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 - CAC Apparatus, Autotransfusion

All 54
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K860306.
PLEURA-GARD ATS
K871568 · Conmedcorp · Jun 1987
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987
SORENSON CATALOG #IFL-120S
K811228 · Sorensen Research · Jun 1981
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · Sorensen Research · Oct 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · Sorensen Research · Oct 1978