Cleared Traditional

K980383 - MOOORLDI LASER DOPPLER IMAGER

K980383 is an FDA 510(k) clearance for MOOORLDI LASER DOPPLER IMAGER, manufactured by Moor Instruments, Ltd.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980383 · Moor Instruments, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
87d
Days
Class 2
Risk

K980383 is an FDA 510(k) clearance for the MOOORLDI LASER DOPPLER IMAGER. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Moor Instruments, Ltd. (Axminster, Devon, GB). The FDA issued a Cleared decision on April 30, 1998 after a review of 87 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 Moor Instruments, Ltd. devices

FDA 510(k) Submission Details - K980383

510(k) Number K980383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date April 30, 1998
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 30
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