Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lada Intl., Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
259 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872833 | BREATHGUARD APNEA MONITOR | Lada Intl., Inc. | 1988-04-01 | 259 | 0 |
| K861410 | LIC MOBILE TRANSPORT STRETCHERS | Lada Intl., Inc. | 1986-04-22 | 7 | 0 |
| K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE | Lada Intl., Inc. | 1983-06-02 | 143 | 0 |
| K830166 | MOLNLYCKE ETE STERILE NON-ADHERENT DRESS | Lada Intl., Inc. | 1983-02-09 | 22 | 0 |
| K830051 | MOLNLYCKE MESALT STERILE DRESSING | Lada Intl., Inc. | 1983-01-26 | 16 | 0 |
| K812141 | LIC OBSTETRICAL TABLE | Lada Intl., Inc. | 1981-08-25 | 28 | 0 |
| K812142 | LIC 180 MEDICAL LAMPS | Lada Intl., Inc. | 1981-08-13 | 16 | 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