Cleared Traditional

K052989 - DP240 240 HOUR DOPPLER PROBE

K052989 is an FDA 510(k) clearance for DP240 240 HOUR DOPPLER PROBE, manufactured by Deltex Medical. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K052989 · Deltex Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
135d
Days
Class 2
Risk

K052989 is an FDA 510(k) clearance for the DP240 240 HOUR DOPPLER PROBE. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Deltex Medical (Chichester, West Sussex, GB). The FDA issued a Cleared decision on March 8, 2006 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K052989

510(k) Number K052989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2005
Decision Date March 08, 2006
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 46
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K052989.
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K013939 · Jostra AG · Dec 2001
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K012747 · Medtronic Perfusion Systems · Sep 2001
K052989 · DP240 240 HOUR DOPPLER PROBE
Download PDF FDA Summary Deltex Medical