Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Moor Instruments, Ltd. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
351 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR HighMoor Instruments, Ltd.2016-05-122320
K132163MOORLDLS-BI LASER DOPPLER BURNS IMAGERMoor Instruments, Ltd.2014-01-292010
K122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.2013-01-031010
K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.2012-10-103780
K102433MOORVMS-PRES PRESSURE CUFF CONTROLLERMoor Instruments, Ltd.2010-11-18840
K083082MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMoor Instruments, Ltd.2009-01-13890
K060976MOORLD12-B1 LASER DOPPLER BURNS IMAGERMoor Instruments, Ltd.2007-03-273510
K063586MOORFLPI FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.2007-01-25550
K063561MOORLDLS LASER DOPPLER LINE SCANNERMoor Instruments, Ltd.2007-01-19530
K032841MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IRMoor Instruments, Ltd.2003-12-10900
K011070DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORMoor Instruments, Ltd.2001-11-072120
K980383MOOORLDI LASER DOPPLER IMAGERMoor Instruments, Ltd.1998-04-30870
K905232MOOR LASER BLOOD FLOW MONITOR MBF3Moor Instruments, Ltd.1991-01-11520
K905233MOOR LASER BLOOD FLOW MONITOR MBF3DMoor Instruments, Ltd.1991-01-11520

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda