Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Innerdyne Medical, Inc. · Predicate Candidate Screening

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

97 daysmedian FDA review time
207 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943253INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.Innerdyne Medical, Inc.1994-10-11970
K943056SINGLE STICK RADIALLY EXPANDING DILATORInnerdyne Medical, Inc.1994-09-27920
K940428INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATORInnerdyne Medical, Inc.1994-04-25840
K940232INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.Innerdyne Medical, Inc.1994-04-18940
K932692INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KITInnerdyne Medical, Inc.1993-12-272070
K931489INTHERM RADIALLY EXPANDING DILATING INTRODUCERInnerdyne Medical, Inc.1993-10-152040

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