Atlas FDA

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

Orion Corp. — Predicate Candidate Screening

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

74 daysmedian FDA review time
259 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912391RUBALEX, MODIFICATIONOrion Corp.1992-05-043460
K901637RESUBMITTED MODIFIED RUBALEXOrion Corp.1990-04-26170
K884650RESUBMITTED SCANORAOrion Corp.1989-03-161290
K890199DENTOCULT SM-STRIP MUTANSOrion Corp.1989-03-02430
K881506MAMEX DC MAG MG12Orion Corp.1988-06-10600
K881505MAMEX DC MG11Orion Corp.1988-06-10600
K874040MAMEX DC S SL10/MG14Orion Corp.1987-11-23490
K872744MODIFIED CHLAMYSET ANTIGENOrion Corp.1987-09-22740
K864457CHLAMYSET ANTIBODY EIAOrion Corp.1987-09-113030
K872301DENTOCULT-SM CULTURE-PADDLEOrion Corp.1987-09-11880
K872058ORICULT-N CULTURE-PADDLEOrion Corp.1987-06-10130
K861883IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1Orion Corp.1986-10-291670
K861882IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN BOrion Corp.1986-10-291670
K863730MYOLEXOrion Corp.1986-10-15220
K862671MICROALBUMINURIA ASSAYOrion Corp.1986-09-18660
K860679IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEINOrion Corp.1986-08-041600
K861881RUBALEX (REVISED VERSION)Orion Corp.1986-06-04270
K853401CHLAMYSET ANTIGENOrion Corp.1986-04-282590
K852788RUBALEXOrion Corp.1986-03-122540
K860529ROTALEXOrion Corp.1986-03-04210
K851164DENTOCULT CULTURE-PADDLEOrion Corp.1985-10-292210

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