Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KEM — Predicate Candidate Screening
15 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
50 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881282 | XYLENE | Anatech, Ltd. | 1988-04-05 | 11 | 0 |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | 1987-12-04 | 36 | 0 |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | 1986-05-06 | 14 | 0 |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | 1986-01-07 | 15 | 0 |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | 1985-10-22 | 48 | 0 |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | 1985-10-22 | 15 | 0 |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | 1984-08-21 | 29 | 0 |
| K842721 | LIMONENE | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | 1983-08-12 | 18 | 0 |
| K832011 | AMERI CLEAR | Stephens Scientific | 1983-08-12 | 50 | 0 |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | 1983-03-24 | 23 | 0 |
| K822784 | HEMO-DE | Pmp Industries | 1982-11-05 | 52 | 0 |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | 1981-10-29 | 20 | 0 |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | 1981-10-29 | 20 | 0 |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 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