Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PZL — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
206 daysmedian FDA review time
521 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025-08-13 | 301 | 0 |
| K250779 | CS-Pro MED | Curative Sound Therapeutics | 2025-07-02 | 110 | 0 |
| K233937 | OW100S | Softwave/Trt, LLC | 2024-07-09 | 208 | 0 |
| K231710 | OW100S | Softwave/Trt, LLC | 2023-09-01 | 81 | 0 |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor | Storz Medical AG | 2021-02-21 | 206 | 0 |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020-08-28 | 143 | 0 |
| K191961 | OrthoGold | Tissue Regeneration Technologies | 2019-11-26 | 126 | 0 |
| DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017-12-28 | 521 | 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