Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DPW — Predicate Candidate Screening
138 FDA 510(k) clearances under this product code; the 50 most recent screened below.
124 daysmedian FDA review time
362 days90th percentile
138clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026-07-08 | 126 | 0 |
| K252810 | FloPatch FP120 | Flosonics Medical | 2026-04-24 | 233 | 0 |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2025-11-20 | 153 | 0 |
| K251114 | FloPatch FP120 | Flosonics Medical | 2025-06-20 | 70 | 0 |
| K243852 | Elfor-L | Elfi-Tech , Ltd. | 2025-04-14 | 119 | 0 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2024-08-30 | 88 | 0 |
| K223843 | FloPatch FP120 | Flosonics Medical | 2023-05-03 | 132 | 1 |
| K222242 | FloPatch FP120 | Flosonics Medical | 2022-12-09 | 136 | 0 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 | 121 | 0 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Pro | Remington Medical, Inc. | 2022-01-27 | 248 | 0 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Pro | Remington Medical, Inc. | 2021-10-07 | 97 | 0 |
| K201114 | Bidop 7 | Koven Technology, Inc. | 2021-01-05 | 253 | 0 |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2020-03-24 | 42 | 1 |
| K192966 | FlowMet | Laser Associated Sciences, Inc. | 2020-01-10 | 79 | 0 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes | Huntleigh Healthcare , Ltd. | 2019-09-06 | 259 | 0 |
| K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 | 28 | 0 |
| K182494 | FlowMet-R | Laser Associated Sciences, Inc. | 2019-02-27 | 169 | 0 |
| K181269 | iCertainty | Rfpi | 2018-12-14 | 214 | 0 |
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018-06-28 | 318 | 0 |
| K152930 | PeriFlux6000 | Perimed AB | 2016-05-05 | 213 | 0 |
| K150268 | CerOX | Or-Nim Medical , Ltd. | 2015-11-06 | 275 | 0 |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | Deltex Medical Limited | 2015-07-24 | 163 | 0 |
| K140740 | TRANSONIC TISSUE PERFUSION MONITOR | Transonic Systems, Inc. | 2015-07-23 | 485 | 0 |
| K132139 | DELTEX MEDICAL CARDIOQ-EDM+ | Deltex Medical Limited | 2013-10-10 | 91 | 0 |
| K131854 | CEROX | Or-Nim Medical , Ltd. | 2013-09-13 | 84 | 0 |
| K111730 | SONOTT FLOWLAB(R) | Em-Tec GmbH | 2012-01-06 | 200 | 0 |
| K112657 | AUREFLO MONITORING SYSTEM | Transonic Systems, Inc. | 2011-12-21 | 99 | 0 |
| K111542 | DELTEX MEDICAL CARDIOQ EDM | Deltex Medical Limited | 2011-10-20 | 140 | 0 |
| K110438 | SENSILASE PAD-IQ | Vasamed, Inc. | 2011-05-04 | 78 | 0 |
| K110347 | DOPPLER MONITOR | Cook Vascular, Inc. | 2011-03-16 | 37 | 0 |
| K102595 | MEDISTIM VERIQC SYSTEM | Medi-Stim Asa | 2010-12-27 | 109 | 1 |
| K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER | Moor Instruments, Ltd. | 2010-11-18 | 84 | 0 |
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | Vascular Technology Incorporated | 2008-10-28 | 29 | 4 |
| K062977 | CRITIVIEW, MODEL CRV3 | Critisense , Ltd. | 2007-02-28 | 152 | 0 |
| K051145 | CRITIVIEW | Critisense , Ltd. | 2006-01-18 | 259 | 0 |
| K052209 | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 | Vascular Control Systems, Inc. | 2005-09-06 | 22 | 0 |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | Koven Technology, Inc. | 2005-04-15 | 37 | 0 |
| K050088 | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL | Neoprobe Corp. | 2005-02-08 | 26 | 0 |
| K041180 | QUANTIX OR VESSEL STABILIZER DEVICE | Cardiosonix, Ltd. | 2004-06-07 | 32 | 0 |
| K040654 | SENSILASE PAD 3000 | Optical Sensors, Inc. | 2004-06-04 | 84 | 0 |
| K040228 | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 | Medi-Stim A/S | 2004-04-29 | 87 | 0 |
| K040909 | SONO TT ULTRASONIC FLOWCOMPUTER | Em-Tec GmbH | 2004-04-20 | 12 | 0 |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | Koven Technology, Inc. | 2004-02-13 | 235 | 0 |
| K033424 | ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RET | Transonic Systems, Inc. | 2003-12-11 | 49 | 0 |
| K031153 | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MO | Arrow Intl., Inc. | 2003-11-25 | 228 | 0 |
| K030357 | QUANTIX/OR DEVICE | Cardiosonix, Ltd. | 2003-08-20 | 198 | 2 |
| K031706 | CARDIOQ, MODEL 9051-7005 | Deltex Medical | 2003-08-06 | 65 | 0 |
| K030505 | CAPIOX CARDIOTOMY RESERVOIR | Terumo Cardiovascular Systems Corp. | 2003-05-14 | 84 | 0 |
| K031091 | VTI 20 MHZ GATED DOPPLER | Vascular Technology Incorporated | 2003-04-23 | 16 | 0 |
| K023431 | QUANTIX/ND DEVICE | Cardiosonix, Ltd. | 2002-11-13 | 29 | 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