Norfolk Medical Products, Inc.: FDA clearances and approvals
Norfolk Medical Products, Inc. has 20 FDA 510(k) clearances (first 1983, latest 2020), across 6 product codes in 1 review panel. Median 510(k) review time: 74 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 363 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Norfolk Medical Products, Inc.'s cleared 510(k)s took a median 363 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 227 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 14 | 14 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| LMQ | Device, Peritoneal Access, Subcutaneous, Implanted | 1 | 1 |
| PTD | Subcutaneous Implanted Apheresis Port | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (19)
Most recent Norfolk Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | PTD | 2020-08-20 | 363 |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | LJT | 2011-10-27 | 38 |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | LJT | 2011-01-14 | 144 |
| K942784 | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED | LJT | 1995-05-02 | 322 |
| K896544 | MD2 PERSONAL INFUSION SYSTEM | FRN | 1990-05-02 | 166 |
| K872838 | NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) | LJT | 1987-08-25 | 36 |
| K871209 | NORFOLK MEDICAL NORPORT | LJT | 1987-06-24 | 91 |
| K871192 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | LJT | 1987-06-10 | 78 |
| K870187 | NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT | LJT | 1987-05-07 | 111 |
| K870519 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | LJT | 1987-04-15 | 68 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Norfolk Medical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Norfolk Medical Products, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Norfolk Medical Products, Inc. have?
Norfolk Medical Products, Inc. has 20 FDA 510(k) clearances (first 1983, latest 2020), across 6 product codes in 1 review panel.
How long does FDA take to clear Norfolk Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Norfolk Medical Products, Inc.'s cleared 510(k)s is 74 days.
What devices does Norfolk Medical Products, Inc. make?
Its most frequent FDA product codes are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 14); FPA (Set, Administration, Intravascular, 2); FRN (Pump, Infusion, 1).
Has Norfolk Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Norfolk Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 20 Norfolk Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Norfolk Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.