Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DPT — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
351 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. | 2024-05-28 | 245 | 0 |
| K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | Spectralmd, Inc. | 2017-08-17 | 262 | 0 |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High | Moor Instruments, Ltd. | 2016-05-12 | 232 | 0 |
| K142932 | Deltex Medical KDP72 Doppler Probe | Deltex Medical Limited | 2015-01-22 | 105 | 0 |
| K132730 | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMED | Medtronic, Inc. | 2014-05-30 | 269 | 0 |
| K133903 | BIO-PROBE TRANSDUCER (ADULT) | Medtronic, Inc. | 2014-04-10 | 111 | 0 |
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | 2014-01-29 | 201 | 0 |
| K124049 | DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM | Spectralmd, Inc. | 2013-04-18 | 108 | 0 |
| K123216 | AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA AR | Aimago SA | 2013-02-07 | 115 | 0 |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | 2013-01-03 | 101 | 0 |
| K121429 | AIMAGO EASYLDI MICROCIRCULATION CAMERA | Aimago SA | 2012-08-10 | 88 | 0 |
| K120884 | PERICAM PSI | Perimed AB | 2012-07-03 | 102 | 0 |
| K073593 | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2 | Deltex Medical Limited | 2009-01-29 | 405 | 0 |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | 2007-03-27 | 351 | 0 |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | 2007-01-25 | 55 | 0 |
| K063561 | MOORLDLS LASER DOPPLER LINE SCANNER | Moor Instruments, Ltd. | 2007-01-19 | 53 | 0 |
| K052989 | DP240 240 HOUR DOPPLER PROBE | Deltex Medical | 2006-03-08 | 135 | 0 |
| K032841 | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR | Moor Instruments, Ltd. | 2003-12-10 | 90 | 0 |
| K013939 | JOSTRA FLOWPROBE FP-32E | Jostra AG | 2001-12-14 | 15 | 0 |
| K012747 | TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP3 | Medtronic Perfusion Systems | 2001-09-14 | 29 | 0 |
| K980383 | MOOORLDI LASER DOPPLER IMAGER | Moor Instruments, Ltd. | 1998-04-30 | 87 | 0 |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | International Biophysics Corp. | 1998-04-08 | 569 | 1 |
| K962700 | VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VEN | Vasamedics, LLC | 1997-04-09 | 271 | 0 |
| K961368 | TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT | Vasamedics, LLC | 1996-10-11 | 185 | 0 |
| K951832 | LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, S | Vasamedics, LLC | 1996-03-21 | 336 | 0 |
| K942377 | TRANSTAR PRESSURE TRANSDUCER | Medex, Inc. | 1994-08-16 | 90 | 3 |
| K924208 | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) | Medtronic Bio-Medicus, Inc. | 1993-07-08 | 322 | 0 |
| K902977 | K3 COMPUTER SYSTEMS | Donald L. King M.D. | 1992-04-28 | 662 | 0 |
| K912404 | TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY | Hewlett-Packard Co. | 1991-11-07 | 161 | 0 |
| K910441 | FLOSCOPE MICRODOP | Advance Medical Device, Inc. | 1991-03-21 | 49 | 0 |
| K905728 | SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1991-03-15 | 81 | 0 |
| K896437 | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM | Kontron Instruments, Inc. | 1990-12-03 | 389 | 0 |
| K896435 | HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM | Hewlett-Packard Co. | 1990-02-07 | 90 | 0 |
| K881303 | TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER | Triton Technology, Inc. | 1988-11-29 | 246 | 0 |
| K874138 | ACCUCOM 2 | Datascope Corp. | 1988-06-01 | 232 | 0 |
| K873214 | APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 | General Electric Co. | 1988-06-01 | 292 | 0 |
| K874861 | ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. | Acuson Computed Sonography | 1988-05-11 | 166 | 0 |
| K875266 | SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM | Toshiba Medical Systems | 1988-04-29 | 129 | 0 |
| K873673 | BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL | Sonicaid, Inc. | 1988-02-26 | 168 | 0 |
| K872441 | HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR | Advanced Technology Laboratories, Inc. | 1988-02-19 | 245 | 0 |
| K871912 | PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM | Electro-Diagnostic Instruments | 1988-02-18 | 276 | 0 |
| K873041 | A-V RECORDER | Life Sciences Manufacturing, Inc. | 1988-02-04 | 184 | 0 |
| K863372 | SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES | Interspec, Inc. | 1986-11-04 | 63 | 0 |
| K860121 | INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER | NuMED, Inc. | 1986-06-02 | 140 | 0 |
| K860435 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER | Multigon Industries, Inc. | 1986-05-05 | 90 | 0 |
| K830858 | BIO-PROBE SYSTEM-BLOOD FLOW PROBE | Bio Medicus, Inc. | 1983-06-08 | 83 | 0 |
| K792015 | P-2 ULTRASONIC ARTERIOGRAPH | D. E. Hokanson, Inc. | 1979-12-04 | 60 | 0 |
| K781413 | MASK, PXYGEN | Vitalab Products Corp. | 1978-09-07 | 23 | 0 |
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