Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAF — Predicate Candidate Screening
38 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
345 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024-12-13 | 114 | 0 |
| K141657 | THD REVOLUTION | Thd Spa | 2015-02-24 | 249 | 0 |
| K110628 | SIMPLEABI | Newman Medical | 2011-05-12 | 70 | 0 |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | 2009-12-24 | 55 | 0 |
| K090009 | THD SLIDE ONE | Thd Spa | 2009-01-28 | 26 | 0 |
| K081429 | THD SLIDE | Thd Spa | 2008-07-30 | 70 | 0 |
| K070815 | THD | G.F. S.R.L. | 2007-06-20 | 86 | 0 |
| K063600 | VISTA AVS | Summit Doppler Systems, Inc. | 2006-12-19 | 15 | 0 |
| K060064 | STETHOFLUX | Odvi | 2006-04-10 | 91 | 0 |
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | 2005-08-29 | 28 | 0 |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | 2001-03-09 | 15 | 0 |
| K982635 | CAREDOP II | Nicolet Biomedical | 1998-08-07 | 25 | 0 |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | 1998-02-05 | 154 | 0 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | 1997-12-29 | 81 | 0 |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | 1997-12-23 | 90 | 0 |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Biosensor Corp. | 1996-04-12 | 640 | 0 |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | Advance Medical Device, Inc. | 1995-11-21 | 504 | 0 |
| K944196 | IMWXDOP IR | Imex Medical Systems, Inc. | 1995-05-12 | 256 | 0 |
| K935427 | R AND D BATTERIES | R & D Batteries, Inc. | 1994-10-21 | 345 | 0 |
| K942441 | IMEXDOP CT+ | Imex Medical Systems, Inc. | 1994-08-23 | 92 | 0 |
| K912925 | ULTRA PVD | Advanced Medical Products, Inc. | 1992-06-18 | 351 | 0 |
| K912033 | ULTRASOUND STETHOSCOPE(R) INTRADOP(R) | Medadonics, Inc. | 1991-10-15 | 159 | 0 |
| K904392 | MULTILAB 2000 | Unetixs, Inc. | 1991-04-29 | 217 | 4 |
| K900882 | MULTI DOPPLEX, MD-1 | Huntleigh Technology, Inc. | 1990-08-22 | 177 | 0 |
| K882018 | MEDACORD PVL, PERSONAL VASCULAR LABORATORY | Medasonics, Inc. | 1988-09-21 | 131 | 0 |
| K854591 | SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 | 156 | 0 |
| K854590 | HANDHELD DOPLER/PEN TRANSDUCER 3MHZ | Philips Medical Systems, Inc. | 1986-04-23 | 156 | 0 |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | Keymed, Inc. | 1985-11-26 | 250 | 0 |
| K852572 | 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 | Siemens Medical Solutions USA, Inc. | 1985-09-19 | 93 | 0 |
| K844128 | EUB-40 | Hitachi Medical Corp. of America | 1985-02-25 | 125 | 0 |
| K843933 | VINGMED DS100 DOPPLER FLOWMETER | Vingmed, Inc. | 1985-02-13 | 131 | 0 |
| K842408 | IREX 730 MECHANICAL SECTOR SCANNER | Irex Corp. | 1984-11-29 | 163 | 0 |
| K822602 | HEMACOUNT WRIGHT GIEMSA STAIN PACK | Accra Laboratories, Inc. | 1982-09-17 | 21 | 0 |
| K800768 | VASCULAB BI-DIRECTIONAL DOPPLER, #D10 | Medasonics, Inc. | 1980-07-08 | 92 | 0 |
| K800096 | AMBIVASON DR-200 | Kt Medical, Inc. | 1980-02-11 | 28 | 0 |
| K800097 | MINIVASON 9 | Kt Medical, Inc. | 1980-02-11 | 28 | 0 |
| K780200 | ULTRASCOPE | L&M Ultrascope Life Monitoring Sys. | 1978-03-02 | 22 | 0 |
| K780201 | SPEAKER-AMPLIFIER & RECORDER INTERFACE | L&M Ultrascope Life Monitoring Sys. | 1978-03-02 | 22 | 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