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

Polyganics B.V., — Predicate Candidate Screening

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

69 daysmedian FDA review time

110 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141816	HEMOPORE	Polyganics B.V.,	2014-10-23	108	0
K141423	NASOPORE-FD	Polyganics B.V.,	2014-08-07	69	0
K112267	NEUROLAC(R) NERVE GUIDE	Polyganics B.V.,	2011-10-20	73	0
K070715	NASOPORE EAR	Polyganics B.V.,	2007-05-07	54	13
K062540	NASOPORE EAR, MODELS ND04, ND05	Polyganics B.V.,	2006-10-18	49	0
K052099	NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ	Polyganics B.V.,	2005-11-21	110	0
K050573	NEUROLAC NERVE GUIDE	Polyganics B.V.,	2005-05-04	58	0
K042811	VIVOSORB SHEET, MODEL FS01	Polyganics B.V.,	2004-11-08	27	0
K032115	NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 02	Polyganics B.V.,	2003-10-10	93	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