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

Witt Biomedical Corp · Predicate Candidate Screening

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

70 daysmedian FDA review time

151 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K101571	XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING	Witt Biomedical Corp	2010-10-26	144	0
K063840	XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR	Witt Biomedical Corp	2007-02-06	42	0
K063547	CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM	Witt Biomedical Corp	2006-12-21	27	0
K040195	CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM	Witt Biomedical Corp	2004-04-07	70	0
K033030	CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION	Witt Biomedical Corp	2004-02-24	151	1

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