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

BXY · Predicate Candidate Screening

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

29 daysmedian FDA review time

87 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K953506	WESTMED RESPIRATORY LUER ADAPTOR	Westmed Intl.	1995-09-15	51
K902916	PRECISION MEDICAL NEB BLOCK	Precision Medical, Inc.	1990-07-23	20
K902917	PRECISION MEDICAL ELIMINATOR	Precision Medical, Inc.	1990-07-23	20
K863510	OXY-OFF(TM)	B&B Medical Technologies, Inc.	1986-10-22	43
K860516	LSP MINILATOR	Life Support Products, Inc.	1986-02-21	10
K851460	NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA	Telectronics, Inc.	1985-05-10	29
K781523	PFT GASES	Gardner Cryogenics	1978-12-01	87

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