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

Sophysa SA — Predicate Candidate Screening

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

262 daysmedian FDA review time

426 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162108	Pressio 2 ICP Monitoring System	Sophysa SA	2017-04-17	262	3
K141227	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE	Sophysa SA	2015-04-02	325	0
K091328	SIPHONX GRAVITATIONAL ANTISIPHON DEVICE	Sophysa SA	2010-01-22	262	0
K090342	POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, S	Sophysa SA	2009-08-11	182	0
K062584	PRESSIO ICP MONITORING SYSTEM	Sophysa SA	2007-07-05	307	2
K042481	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SP	Sophysa SA	2004-12-14	92	0
K031097	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SP	Sophysa SA	2004-02-26	325	0
K013488	SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8	Sophysa SA	2002-03-27	159	0
K992465	SOPHY SU8 PRESSURE ADJUSTABLE VALVE	Sophysa SA	2000-09-21	426	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