Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Navarre Biomedical , Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
365 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955110 | NAVARRE PERCUTANEOUS BILIARY DRAINAGE | Navarre Biomedical , Ltd. | 1996-11-07 | 365 | 0 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 | 68 | 0 |
| K945909 | NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER | Navarre Biomedical , Ltd. | 1995-06-02 | 182 | 0 |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-05-15 | 21 | 0 |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-04-24 | 25 | 0 |
| K943663 | NAVARRE 600 ML DRAINAGE BAG | Navarre Biomedical , Ltd. | 1994-09-08 | 42 | 0 |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Navarre Biomedical , Ltd. | 1994-07-08 | 56 | 0 |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | Navarre Biomedical , Ltd. | 1994-03-28 | 244 | 0 |
| K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET | Navarre Biomedical , Ltd. | 1994-01-27 | 254 | 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