Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LLK · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903532 | UNNA-SLEEVE(TM) | Aci Medical, Inc. | 1990-11-02 | 88 | 0 |
| K873368 | TECNOL COMPRESSION KNEE DRESSING | Tecnol New Jersey Wound Care, Inc. | 1987-12-11 | 112 | 0 |
| K871889 | COMPRESSION LEGGING DEVICE | A-T Surgical Mfg. Co., Inc. | 1987-08-04 | 81 | 0 |
| K834460 | MODEL 1888 ALPHA COS/RESPIRATION CAR | Spacelabs, Inc. | 1984-02-13 | 56 | 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