Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Portlyn Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
189 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970083 | DYNABITE HOT GI BIOPSY FORCEPS | Portlyn Corp. | 1997-06-17 | 159 | 0 |
| K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | Portlyn Corp. | 1995-07-27 | 120 | 0 |
| K952391 | DYNABITE UROLOGICAL FORCEPS | Portlyn Corp. | 1995-06-01 | 10 | 0 |
| K944245 | DYNABITE LAPAROSCOPIC FORCEPS | Portlyn Corp. | 1994-11-15 | 77 | 0 |
| K934506 | DYNABITE HYSTEROSCOPIC FORCEPS | Portlyn Corp. | 1994-03-22 | 189 | 0 |
| K901300 | BIOPSY FORCEPS | Portlyn Corp. | 1990-06-29 | 101 | 0 |
| K896147 | BIOPSY FORCEP (NON-ELECTRIC) | Portlyn Corp. | 1990-04-16 | 175 | 0 |
| K896146 | BIOPSY FORCEPS, (NON-RIGID) | Portlyn Corp. | 1990-03-09 | 137 | 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