Atlas FDA

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

Gds Technology, LLC — Predicate Candidate Screening

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

69 daysmedian FDA review time
340 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994073HEMOSITE TEST SYSTEMGds Technology, LLC2000-01-14430
K992132CHOLESITE TEST SYSTEMGds Technology, LLC1999-08-20580
K973649HEMOSITE TEST SYSTEMGds Technology, LLC1998-08-313400
K971145GLUCOSITE TEST SYSTEMGds Technology, LLC1997-09-171730
K911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONGds Technology, LLC1991-07-01690
K882038GDS ENZYMATIC SALICYLATE REAGENTGds Technology, LLC1988-06-24390
K880829GDS ENZYMATIC ACETAMINOPHEN REAGENTGds Technology, LLC1988-05-27870

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