Cleared Traditional

K830858 - BIO-PROBE SYSTEM-BLOOD FLOW PROBE

K830858 is the FDA 510(k) clearance for BIO-PROBE SYSTEM-BLOOD FLOW PROBE by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DPT) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K830858 · Bio Medicus, Inc. · Cardiovascular device
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Jun 1983
Decision
83d
Days
Class 2
Risk

K830858 is an FDA 510(k) clearance for the BIO-PROBE SYSTEM-BLOOD FLOW PROBE. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight 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 Bio Medicus, Inc. devices

Submission Details

510(k) Number K830858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1983
Decision Date June 08, 1983
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 Cardiovascular devices follow this clearance model.