Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Norfolk Medical Products, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
322 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020-08-20 | 363 | 0 |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-10-27 | 38 | 0 |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-01-14 | 144 | 0 |
| K942784 | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED | Norfolk Medical Products, Inc. | 1995-05-02 | 322 | 0 |
| K896544 | MD2 PERSONAL INFUSION SYSTEM | Norfolk Medical Products, Inc. | 1990-05-02 | 166 | 0 |
| K872838 | NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) | Norfolk Medical Products, Inc. | 1987-08-25 | 36 | 0 |
| K871209 | NORFOLK MEDICAL NORPORT | Norfolk Medical Products, Inc. | 1987-06-24 | 91 | 0 |
| K871192 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Norfolk Medical Products, Inc. | 1987-06-10 | 78 | 0 |
| K870187 | NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT | Norfolk Medical Products, Inc. | 1987-05-07 | 111 | 0 |
| K870519 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Norfolk Medical Products, Inc. | 1987-04-15 | 68 | 0 |
| K870188 | NORFOLK MEDICAL BUTTERFLY INFUSION SET | Norfolk Medical Products, Inc. | 1987-02-10 | 25 | 0 |
| K863723 | NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT | Norfolk Medical Products, Inc. | 1986-10-29 | 36 | 0 |
| K863721 | NORFOLK MEDICAL POSI-GRIP 'HUBER POINT' NEEDLE | Norfolk Medical Products, Inc. | 1986-10-14 | 21 | 0 |
| K854593 | NORFOLK MEDICAL PERITONEAL-ACCESS PORT | Norfolk Medical Products, Inc. | 1986-02-04 | 78 | 0 |
| K841679 | VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD | Norfolk Medical Products, Inc. | 1984-06-28 | 66 | 0 |
| K840788 | VASCULAR ACCESS PORT CHANGES IN MATER | Norfolk Medical Products, Inc. | 1984-04-24 | 109 | 0 |
| K841149 | VASCULAR-ACCESS PORT - ENLARGEMENT | Norfolk Medical Products, Inc. | 1984-04-24 | 109 | 0 |
| K841150 | VASCULAR-ACCESS PORT CHANGE CATHETER | Norfolk Medical Products, Inc. | 1984-04-24 | 47 | 0 |
| K823845 | PORT-LOCK | Norfolk Medical Products, Inc. | 1983-03-01 | 70 | 0 |
| K830000 | VASCULAR-ACCESS-PORT | Norfolk Medical Products, Inc. | 1983-03-01 | 57 | 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