Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mediplus , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132890 | SUPRAPUBIC CATHETER AND INTRODUCER SET | Mediplus , Ltd. | 2014-01-17 | 123 | 0 |
| K131339 | CAPNOMASK | Mediplus , Ltd. | 2013-11-25 | 200 | 0 |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | 2004-01-16 | 238 | 0 |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | 2002-08-05 | 270 | 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