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

Filtertek, Inc. — Predicate Candidate Screening

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

76 daysmedian FDA review time
154 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981547NFC NEEDLEFREE Y-SITE, MODEL 69970Filtertek, Inc.1998-06-18490
K981548NFC NEEDLEFREE CONNECTOR MODEL 69900Filtertek, Inc.1998-06-18490
K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SETFiltertek, Inc.1992-01-15840
K912848I.V. FILTER EXTENSION SETFiltertek, Inc.1991-11-291540
K912394TRANSDUCER PROTECTORFiltertek, Inc.1991-08-30940
K911451I.V. EXTENDER SETFiltertek, Inc.1991-06-06640
K904912TRANSDUCER PROTECTORFiltertek, Inc.1991-01-04650
K901409TRANSDUCER PROTECTORFiltertek, Inc.1990-07-271230
K901996FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTORFiltertek, Inc.1990-06-01300
K895281TRANSDUCER PROTECTORFiltertek, Inc.1989-11-08760

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