Atlas FDA

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

KSX — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

44 daysmedian FDA review time
95 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.1980-11-12280
K802534GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.1980-11-12280
K800916P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.1980-05-08160
K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.1978-12-20440
K781895BLOOD GROUP SUBSTANCE BNorth American Biologicals, Inc.1978-12-20440
K781896BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.1978-12-20440
K771487LEWIS BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.1977-11-08950
K771488P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.1977-11-08950

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