Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mid-Atlantic Diagnostics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100596 | CRYOPETTE | Mid-Atlantic Diagnostics, Inc. | 2010-12-06 | 279 | 1 |
| K041435 | THE STRIPPER PGD | Mid-Atlantic Diagnostics, Inc. | 2004-09-29 | 124 | 0 |
| K030525 | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, | Mid-Atlantic Diagnostics, Inc. | 2003-08-27 | 189 | 0 |
| K993699 | THE STRIPPER | Mid-Atlantic Diagnostics, Inc. | 2000-05-16 | 196 | 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