Atlas FDA

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

Osprey Medical, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
153 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast MOsprey Medical, Inc.2019-10-172680
K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ ContOsprey Medical, Inc.2018-12-20270
K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.2018-10-25980
K171698Smart SyringeOsprey Medical, Inc.2017-07-07290
K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Osprey Medical, Inc.2017-05-26300
K163054DyeVert Plus Contrast Modulation/Monitoring System, ContrastOsprey Medical, Inc.2017-03-081270
K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.2016-08-03630
K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.2016-02-04970
K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.2015-10-151530
K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.2015-10-091020
K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.2015-03-26300
K142081CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTOsprey Medical, Inc.2014-12-121340
K140425CONTRAST MODULATION SYSTEMOsprey Medical, Inc.2014-06-111120
K131478CONTRAST CONSERVATION SYSTEMOsprey Medical, Inc.2013-08-15850

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