Cleared Traditional

K803099 - BIOFEEDBACK BIO 80

K803099 is an FDA 510(k) clearance for BIOFEEDBACK BIO 80, manufactured by Bimed, Inc.. The device is a Class 2 Hematology device with product code HCC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K803099 · Bimed, Inc. · Hematology device
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Mar 1981
Decision
84d
Days
Class 2
Risk

K803099 is an FDA 510(k) clearance for the BIOFEEDBACK BIO 80. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Bimed, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1981 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 882.5050 - 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.

FDA 510(k) Submission Details - K803099

510(k) Number K803099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date March 02, 1981
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 169
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K803099.
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS
K810881 · Atlas Researches , Ltd. · May 1981
ASR-3520 SKIN RESPONSE MONITOR
K810882 · Atlas Researches , Ltd. · May 1981
SC/TEMP 300
K810332 · Thought Technology , Ltd. · May 1981
EMG-UT 30
K802390 · American Scientific Corp. · Jan 1981
EMG-UT 40
K802391 · American Scientific Corp. · Jan 1981
BIOFEEDBACK DEVICES & ACCESSORIES
K792115 · M.O.E Electronics Research & Prod. · Mar 1980
K803099 · BIOFEEDBACK BIO 80
Download PDF Bimed, Inc.