Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wien Laboratories, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
59 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912850 | SHBG | Wien Laboratories, Inc. | 1991-08-12 | 45 | 0 |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Wien Laboratories, Inc. | 1984-02-04 | 59 | 0 |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | 1983-09-12 | 49 | 0 |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | Wien Laboratories, Inc. | 1982-11-29 | 34 | 0 |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 | 11 | 0 |
| K821652 | DOXEPIN TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 | 11 | 0 |
| K802728 | 125I-TESTOSTERONE TEST SET | Wien Laboratories, Inc. | 1980-12-11 | 38 | 0 |
| K792041 | DHEA-SULFATE TEST SET | Wien Laboratories, Inc. | 1979-10-30 | 18 | 0 |
| K781834 | TEST SET, 125 I-DIGOXIN | Wien Laboratories, Inc. | 1979-01-03 | 65 | 0 |
| K781599 | I-ESTRIOL TEST SET | Wien Laboratories, Inc. | 1978-10-17 | 29 | 0 |
| K772306 | 125I DIGOXIN TEST SET | Wien Laboratories, Inc. | 1977-12-22 | 7 | 0 |
| K771793 | DHEA TEST SET | Wien Laboratories, Inc. | 1977-11-02 | 41 | 0 |
| K771729 | 17-HYDROXYPROGESTERONE TEST SET | Wien Laboratories, Inc. | 1977-10-21 | 37 | 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