Atlas FDA

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

Scientific Device Manufacturer, LLC · Predicate Candidate Screening

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

194 daysmedian FDA review time
423 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K960764SAFE-CATHScientific Device Manufacturer, LLC1997-04-244230
K960431PRESSURE STOPCOCK/MANIFOLDScientific Device Manufacturer, LLC1996-10-292720
K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLC1996-10-151940
K960430CONTROL SYRINGEScientific Device Manufacturer, LLC1996-08-061880
K960917PERCUGLIDEScientific Device Manufacturer, LLC1996-07-021180
K952579TOCO TRANSDUCERScientific Device Manufacturer, LLC1995-08-04600

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