Atlas FDA

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

Diag Corp. · Predicate Candidate Screening

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

99 daysmedian FDA review time
214 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229Diag Corp.1999-03-241280
K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCERDiag Corp.1991-11-292140
K910645DISPOSABLE PATIENT CABLEDiag Corp.1991-05-07830
K852446ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIPDiag Corp.1985-09-17990
K820003CARDIOVASCULAR TEMP. PACEMAKER ELECDiag Corp.1982-03-26810
K820262PERMANENT & TEMPORARY PACEMAKER ELECTR.Diag Corp.1982-03-12380
K812905PERMANENT ENDOCARD. UNIPOLAR TINED LEADDiag Corp.1982-02-041080
K812270PERM. ENDOCARDIAL UNIPOLAR TINED ATRIALDiag Corp.1981-09-16340
K800349ENDOCARD. PACING LEAD LONG LENGTH PL200Diag Corp.1980-05-281030

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