Harbor Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Harbor Medical Devices, Inc.” (first 1988, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 | 3 |
| DQR | Cannula, Catheter | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
- General Hospital (4)
- Cardiovascular (3)
Most recent Harbor Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884628 | HARBORIN CENTRAL VENOUS CATHETER | DQR | 1989-05-15 | 189 |
| K890518 | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM | LJT | 1989-04-21 | 78 |
| K882657 | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT | DYB | 1988-12-13 | 167 |
| K881884 | HARBOR CENTRAL VENOUS CATHETER | DQR | 1988-07-28 | 85 |
| K882190 | S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM | LJT | 1988-06-09 | 16 |
| K880297 | SEA - PORT INFUSION SET | LJT | 1988-02-19 | 25 |
| K874414 | HYPODERMIC NEEDLES, SINGLE LUMEN | FMI | 1988-01-14 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Harbor Medical Devices, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Harbor Medical, Inc. (2 510(k)s)
- Harbor Medtech, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harbor Medical Devices, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Harbor Medical Devices, Inc.” (first 1988, latest 1989), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Harbor Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harbor Medical Devices, Inc. is 78 days.
Which FDA product codes appear under Harbor Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 3); DQR (Cannula, Catheter, 2); DYB (Introducer, Catheter, 1).
Next steps
- See all 7 Harbor Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Harbor Medical Devices, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.