Atlas FDA

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

Orthion Corp. — Predicate Candidate Screening

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

16 daysmedian FDA review time
20 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832546MARK V HIGH VOLTAGE GALVANIC STIMULATORROrthion Corp.1983-10-14770
K823153BATH TUB SEAT & BATH BOARDOrthion Corp.1982-11-05160
K823150SESAM TREATMENT TABLEOrthion Corp.1982-11-05160
K823149OB TILT TABLEOrthion Corp.1982-11-05160
K823105RESI-WALKEROrthion Corp.1982-11-05160
K823154SHOWER STOOL W/HANDLESOrthion Corp.1982-11-05160
K823152OB HELP ARMOrthion Corp.1982-11-05160
K823151OB TRIPP TRANSPORT CHAIROrthion Corp.1982-11-05160
K823155LAVATORY SEAT HEIGHTENEROrthion Corp.1982-11-05160
K823156COLLAPSABLE LAVATORY HEIGHTENEROrthion Corp.1982-11-05160
K812701ORTHO-THERM INFRARED SENSOROrthion Corp.1981-10-13200

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