Atlas FDA

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

Trend Scientific, Inc. — Predicate Candidate Screening

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

178 daysmedian FDA review time
281 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954996TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTETrend Scientific, Inc.1996-08-082810
K955755TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMSTrend Scientific, Inc.1996-07-112040
K952467TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)Trend Scientific, Inc.1995-11-201780
K953284TREND GIARDIA DIRECT DETECTION RS TEST SYSTEMTrend Scientific, Inc.1995-10-06850
K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDETrend Scientific, Inc.1986-09-16460
K830769FEKAL CON-TRATE SYSTEMTrend Scientific, Inc.1983-04-05250

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