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

Innerdyne, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
206 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992668INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)Innerdyne, Inc.2000-05-262910
K990854INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICEInnerdyne, Inc.1999-08-021400
K990493INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICEInnerdyne, Inc.1999-05-18900
K982417INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPInnerdyne, Inc.1998-10-07860
K980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARINInnerdyne, Inc.1998-09-112060
K972684INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEMInnerdyne, Inc.1997-10-10850
K971230SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUSInnerdyne, Inc.1997-06-13720
K970754INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEPInnerdyne, Inc.1997-04-21490
K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEPInnerdyne, Inc.1996-07-10511
K961430INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEPInnerdyne, Inc.1996-05-28430
K950658INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:Innerdyne, Inc.1995-05-12880
K950632INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPInnerdyne, Inc.1995-05-12880

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