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

Polystan C/O Vitalcor, Inc. — Predicate Candidate Screening

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

218 daysmedian FDA review time
247 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894657POLYSTAN HEART-LUNG MACHINE SYSTEMPolystan C/O Vitalcor, Inc.1990-03-282470
K893940POLYSTAN HEATER-COOLER UNITPolystan C/O Vitalcor, Inc.1990-01-182320
K893704SAFE-1Polystan C/O Vitalcor, Inc.1989-12-222180
K893705SAFE-1 VENOUS RESERVOIRPolystan C/O Vitalcor, Inc.1989-12-222180
K874853POLYSTAN TWO STAGE CATHETERSPolystan C/O Vitalcor, Inc.1988-02-05720
K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSPolystan C/O Vitalcor, Inc.1988-02-05720
K872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAEPolystan C/O Vitalcor, Inc.1987-10-301440
K843538PO 2 LYTRODEPolystan C/O Vitalcor, Inc.1984-10-18410

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