Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L H M Ent., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
238 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | L H M Ent., Inc. | 1990-05-18 | 72 | 0 |
| K901078 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE | L H M Ent., Inc. | 1990-05-18 | 72 | 0 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 | 238 | 0 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | L H M Ent., Inc. | 1990-02-15 | 17 | 0 |
| K894611 | CATHETER CARE KITS | L H M Ent., Inc. | 1989-12-15 | 148 | 0 |
| K883506 | IRRIGATION KIT | L H M Ent., Inc. | 1988-12-13 | 118 | 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