Cleared Traditional

K013939 - JOSTRA FLOWPROBE FP-32E

K013939 is the FDA 510(k) clearance for JOSTRA FLOWPROBE FP-32E by Jostra AG. It is a Class 2 Cardiovascular device (product code DPT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K013939 · Jostra AG · Cardiovascular device
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Dec 2001
Decision
15d
Days
Class 2
Risk

K013939 is an FDA 510(k) clearance for the JOSTRA FLOWPROBE FP-32E. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Jostra AG (Oxford, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 15 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 Jostra AG devices

Submission Details

510(k) Number K013939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2001
Decision Date December 14, 2001
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 13
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