Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Norfolk Medical — 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) |
|---|---|---|---|---|---|
| K151341 | Turbo High-Flow Non-coring Needle | Norfolk Medical | 2015-08-20 | 93 | 0 |
| K111101 | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET | Norfolk Medical | 2011-08-25 | 127 | 0 |
| K911067 | NORCATH VASCULAR ACCESS CATHETERS | Norfolk Medical | 1991-06-03 | 84 | 0 |
| K905646 | OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY | Norfolk Medical | 1991-03-27 | 100 | 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