Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLQ — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
322 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025-04-17 | 56 | 0 |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025-01-15 | 90 | 0 |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023-12-21 | 101 | 0 |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023-08-30 | 128 | 0 |
| K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019-12-04 | 195 | 0 |
| K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017-07-12 | 253 | 0 |
| K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016-06-30 | 58 | 0 |
| DEN150001 | RELIZORB | Alcresta, Inc. | 2015-11-20 | 322 | 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