Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Localmed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
347 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980957 | KAPLAN-SIMPSON INFUSASLEEVE II | Localmed, Inc. | 1998-06-10 | 86 | 0 |
| K972175 | INFUSASLEEVE IIA (IS-2A) | Localmed, Inc. | 1997-08-28 | 80 | 0 |
| K952317 | Kaplan-Simpson InfusaSleeve II Catheter | Localmed, Inc. | 1995-06-28 | 42 | 0 |
| K950615 | KAPLAN-SIMPSON INFUSASLEEVE CATHETER | Localmed, Inc. | 1995-04-19 | 68 | 0 |
| K935349 | LOCALMED INFUSION CATHETER | Localmed, Inc. | 1994-10-18 | 347 | 0 |
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