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

Vxtra Corp. — Predicate Candidate Screening

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

47 daysmedian FDA review time

86 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K832980	VXTRA OCUTOME KIT	Vxtra Corp.	1983-10-19	47
K832938	OCUTOME PARATUBING SET	Vxtra Corp.	1983-10-19	47
K831266	MICROSURGICAL KNIFE	Vxtra Corp.	1983-06-10	53
K830379	PHAKO KIT	Vxtra Corp.	1983-04-05	60
K830385	IRRIGATION/ASPIRATION KIT	Vxtra Corp.	1983-04-05	60
K812620	ADJUSTABLE MICROSURGICAL KNIFE	Vxtra Corp.	1981-10-19	34
K812526	MICRO BLADE II	Vxtra Corp.	1981-09-16	14
K812160	MICROSURGICAL BLADE	Vxtra Corp.	1981-08-31	33
K800557	DISPOSABLE PRE-GELLED ELECTROSURGICAL	Vxtra Corp.	1980-04-21	40
K792436	VXTRA BACK PACK EKG ELECTRODE CAT. NO.	Vxtra Corp.	1980-02-22	86

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