Cleared Traditional

K013939 - JOSTRA FLOWPROBE FP-32E

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

K013939 · Jostra AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K013939

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.

DPT Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K013939.
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
K063586 · Moor Instruments, Ltd. · Jan 2007
MOORLDLS LASER DOPPLER LINE SCANNER
K063561 · Moor Instruments, Ltd. · Jan 2007
DP240 240 HOUR DOPPLER PROBE
K052989 · Deltex Medical · Mar 2006
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · Medtronic Perfusion Systems · Sep 2001
MOOORLDI LASER DOPPLER IMAGER
K980383 · Moor Instruments, Ltd. · Apr 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · International Biophysics Corp. · Apr 1998