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

Koven and Assoc., Inc. · Predicate Candidate Screening

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

231 daysmedian FDA review time
365 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922669MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOWKoven and Assoc., Inc.1993-01-292390
K920333SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTORKoven and Assoc., Inc.1993-01-223610
K915550MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTORKoven and Assoc., Inc.1992-12-103650
K913595DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEMKoven and Assoc., Inc.1992-03-272270
K912409MODEL HD-207 BIDIRECTIONAL VELOCITY METERKoven and Assoc., Inc.1991-12-232060
K903026ES-1000SP II SMART DOPKoven and Assoc., Inc.1991-02-262310
K894892HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEMKoven and Assoc., Inc.1989-10-27870
K892707DVM-4200 BLOOD FLOWMETERKoven and Assoc., Inc.1989-07-281050

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