Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Progressive Concepts, 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) |
|---|---|---|---|---|---|
| K940600 | STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ | Progressive Concepts, Inc. | 1995-09-29 | 596 | 0 |
| K941959 | VERSATELL; VERSATELL-S | Progressive Concepts, Inc. | 1995-06-21 | 425 | 0 |
| K946298 | BIOSTIM-HV | Progressive Concepts, Inc. | 1995-05-11 | 135 | 0 |
| K940349 | NEUROMUSCULAR ELECTRICAL STIMULATOR | Progressive Concepts, Inc. | 1994-04-01 | 66 | 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