Atlas FDA

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

Nitinol Medical Technologies, Inc. · Predicate Candidate Screening

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

157 daysmedian FDA review time
270 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970099SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMNitinol Medical Technologies, Inc.1997-04-16930
K963016SIMON NITINOL FILTER SYSTEMNitinol Medical Technologies, Inc.1996-11-181080
K963014SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMNitinol Medical Technologies, Inc.1996-11-181080
K944353SIMON NITINOL FILTERNitinol Medical Technologies, Inc.1995-04-282410
K940489SIMON NITINOL FILTERNitinol Medical Technologies, Inc.1994-08-091960
K912144SIMON NITINOL FILTER, MODIFICATIONNitinol Medical Technologies, Inc.1991-10-171570
K894703SIMON NITINOL FILTERNitinol Medical Technologies, Inc.1990-04-202700

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