Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koven Technology, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
204 daysmedian FDA review time
439 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201114 | Bidop 7 | Koven Technology, Inc. | 2021-01-05 | 253 | 0 |
| K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016-05-25 | 147 | 0 |
| K143332 | Fast Sphyg by Koven | Koven Technology, Inc. | 2015-04-14 | 145 | 0 |
| K131623 | SMARTDOP XT | Koven Technology, Inc. | 2014-01-17 | 227 | 0 |
| K080178 | VALVULOTOME BY KOVEN | Koven Technology, Inc. | 2008-07-28 | 186 | 0 |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | Koven Technology, Inc. | 2005-04-15 | 37 | 0 |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | Koven Technology, Inc. | 2004-02-13 | 235 | 0 |
| K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX | Koven Technology, Inc. | 2003-07-18 | 65 | 0 |
| K023143 | ECHO SOUNDER, ES-102EX | Koven Technology, Inc. | 2002-12-19 | 90 | 0 |
| K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 43 | Koven Technology, Inc. | 2002-02-12 | 362 | 0 |
| K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 | Koven Technology, Inc. | 1998-11-24 | 90 | 0 |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | 1997-07-23 | 439 | 0 |
| K963274 | V-LINK 3.2 FOR WINDOWS | Koven Technology, Inc. | 1996-10-31 | 72 | 0 |
| K951449 | MODEL KM-25 | Koven Technology, Inc. | 1996-05-20 | 418 | 0 |
| K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY | Koven Technology, Inc. | 1996-03-29 | 191 | 1 |
| K935994 | PW DOPPLER VASCULAR PROBES | Koven Technology, Inc. | 1995-05-11 | 512 | 0 |
| K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR | Koven Technology, Inc. | 1994-12-23 | 204 | 0 |
| K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW | Koven Technology, Inc. | 1994-05-13 | 231 | 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