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

Biopool AB — Predicate Candidate Screening

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

122 daysmedian FDA review time

535 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K941752	SPECTROLYSE ANTIPLASMIN KIT	Biopool AB	1995-09-25	535	0
K942087	BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES	Biopool AB	1995-07-13	437	0
K934314	TINTELIZER(R) TPA	Biopool AB	1994-02-23	175	0
K923499	SPECTROLYSE HEPARIN KIT	Biopool AB	1994-01-27	561	0
K932463	BIOCLOT LA	Biopool AB	1993-09-27	129	0
K920668	MINUTEX D-DIMER LATEX TEST	Biopool AB	1992-10-16	246	1
K922782	SPECTROLYSE/PL PAI KIT	Biopool AB	1992-10-09	122	0
K915163	PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES	Biopool AB	1992-01-06	53	0
K914307	SPECTROLYSE PROTEIN C KIT	Biopool AB	1991-12-09	75	0
K912025	SPECTROLYSE PLASMINOGEN SK KIT	Biopool AB	1991-08-22	107	0
K902566	BIOPOOL PROTEIN C EID KIT AND BULK PLATES	Biopool AB	1990-08-09	59	0
K902530	SPECTROLYSE ATIII KIT	Biopool AB	1990-08-09	65	0
K902528	BIOCLOT C KIT	Biopool AB	1990-08-09	65	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