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

Bionix Development Corp. — Predicate Candidate Screening

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

81 daysmedian FDA review time

117 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K153270	TruGuard Custom Tongue and Jaw Positioner	Bionix Development Corp.	2016-03-08	117
K123411	LITTLE ANGELS SWADDLING BLANKET	Bionix Development Corp.	2013-03-07	122
K120335	EMBRACE THERMOPLASTIC	Bionix Development Corp.	2012-05-03	90
K100691	OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500	Bionix Development Corp.	2010-05-11	62
K100264	T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060	Bionix Development Corp.	2010-04-09	71
K050701	THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010	Bionix Development Corp.	2005-04-01	14
K040773	PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM	Bionix Development Corp.	2004-04-09	14
K030051	VERSABOARD, MODEL 7040	Bionix Development Corp.	2003-04-04	88
K933613	3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMO	Bionix Development Corp.	1993-10-07	80
K933614	PITUITARY BOARD	Bionix Development Corp.	1993-10-07	80
K905007	STANDARD BREAST BOARDS; DELUXE BREAST BOARD	Bionix Development Corp.	1991-02-12	98
K900370	ONE/CIRC (CIRCUMCISION CLAMP)	Bionix Development Corp.	1990-04-16	81

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