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

Spire Biomedical, Inc. — Predicate Candidate Screening

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

89 daysmedian FDA review time

202 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073092	DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TI	Spire Biomedical, Inc.	2008-01-29	89	0
K073093	DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARAT	Spire Biomedical, Inc.	2008-01-22	82	0
K063441	15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19S	Spire Biomedical, Inc.	2007-02-12	90	48
K063431	15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CAT	Spire Biomedical, Inc.	2007-01-29	77	48
K062435	REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS	Spire Biomedical, Inc.	2006-12-05	106	0
K060288	RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETE	Spire Biomedical, Inc.	2006-09-01	207	0
K060155	15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATH	Spire Biomedical, Inc.	2006-05-09	109	47
K042858	55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEP	Spire Biomedical, Inc.	2004-12-03	49	48
K041559	55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHET	Spire Biomedical, Inc.	2004-07-30	50	0
K040509	ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19	Spire Biomedical, Inc.	2004-04-19	52	48
K032061	DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODEL	Spire Biomedical, Inc.	2003-12-23	173	48
K022644	RETRO REPAIR KIT, MODEL PRRK5	Spire Biomedical, Inc.	2002-11-06	90	0
K022620	SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRI	Spire Biomedical, Inc.	2002-10-11	65	0
K022000	POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH	Spire Biomedical, Inc.	2002-07-19	30	0
K021212	24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHET	Spire Biomedical, Inc.	2002-05-17	30	0
K013160	POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER	Spire Biomedical, Inc.	2002-04-11	202	0

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