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

Lic-Orthion — Predicate Candidate Screening

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

19 daysmedian FDA review time

73 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K891649	PATIENT EXAMINATION GLOVES (LATEX)	Lic-Orthion	1989-04-04	18
K862022	LIC-ORTHION MULTI-THERAPY TREATMENT TABLE	Lic-Orthion	1986-06-19	22
K854730	DAISY (ABSORBENT INCONTINENCE SHIELD)	Lic-Orthion	1986-02-06	73
K854729	ADAM (ABSORBENT INCONTINENCE SHIELD)	Lic-Orthion	1986-02-06	73
K851470	BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR	Lic-Orthion	1985-06-12	58
K851471	TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR	Lic-Orthion	1985-06-12	58
K843234	CITOMAT AUTOCLAVES	Lic-Orthion	1984-10-25	69
K843233	ANATOM SYSTEM	Lic-Orthion	1984-10-25	69
K830853	LAVATORY SEAT HEIGHTENER	Lic-Orthion	1983-06-08	83
K830854	COLLAPSABLE LAVATORY SEAT HEIGHTENER	Lic-Orthion	1983-04-05	19
K830855	SESAM TREATMENT TABLE	Lic-Orthion	1983-04-05	19
K830848	RESI-WALKER	Lic-Orthion	1983-04-05	19
K830849	OB TILT	Lic-Orthion	1983-04-05	19
K830842	OB HELP ARM	Lic-Orthion	1983-04-05	19
K830852	SHOWER STOOL W/HANDLES	Lic-Orthion	1983-04-05	19
K830850	OB TRIPP TRANSPORT CHAIR	Lic-Orthion	1983-04-05	19
K830851	BATH TUB SEAT & BATH BOARD	Lic-Orthion	1983-04-05	19

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