Cleared Traditional

K152749 - moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152749 · Moor Instruments, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
232d
Days
Class 2
Risk

K152749 is an FDA 510(k) clearance for the moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infra.... Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Moor Instruments, Ltd. (Axminster, GB). The FDA issued a Cleared decision on May 12, 2016 after a review of 232 days - an extended review 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: 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.

View all Moor Instruments, Ltd. devices

Submission Details

510(k) Number K152749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2015
Decision Date May 12, 2016
Days to Decision 232 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 125d · This submission: 232d
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.