Portlyn Corp.: FDA clearances and approvals
Portlyn Corp. has 8 FDA 510(k) clearances (first 1990, latest 1997), across 5 product codes in 4 review panels. Median 510(k) review time: 128 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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | 2 | 2 |
| FCL | Forceps, Biopsy, Non-Electric | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
Review panels
- Gastroenterology and Urology (3)
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
Most recent Portlyn Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970083 | DYNABITE HOT GI BIOPSY FORCEPS | KGE | 1997-06-17 | 159 |
| K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | DWZ | 1995-07-27 | 120 |
| K952391 | DYNABITE UROLOGICAL FORCEPS | FCL | 1995-06-01 | 10 |
| K944245 | DYNABITE LAPAROSCOPIC FORCEPS | HET | 1994-11-15 | 77 |
| K934506 | DYNABITE HYSTEROSCOPIC FORCEPS | HET | 1994-03-22 | 189 |
| K901300 | BIOPSY FORCEPS | DWZ | 1990-06-29 | 101 |
| K896147 | BIOPSY FORCEP (NON-ELECTRIC) | FCL | 1990-04-16 | 175 |
| K896146 | BIOPSY FORCEPS, (NON-RIGID) | EOQ | 1990-03-09 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Portlyn Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does Portlyn Corp. have?
Portlyn Corp. has 8 FDA 510(k) clearances (first 1990, latest 1997), across 5 product codes in 4 review panels.
How long does FDA take to clear Portlyn Corp.'s 510(k)s?
The median time from FDA receipt to decision across Portlyn Corp.'s cleared 510(k)s is 128 days.
What devices does Portlyn Corp. make?
Its most frequent FDA product codes are DWZ (Device, Biopsy, Endomyocardial, 2); FCL (Forceps, Biopsy, Non-Electric, 2); HET (Laparoscope, Gynecologic (And Accessories), 2).
Has Portlyn Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Portlyn Corp. Related entities may recall under other names.
Next steps
- See all 8 Portlyn Corp. clearances with predicates and recalls
- Run predicate analysis for product code DWZ, Portlyn Corp.'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.