Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L.O.N. Research, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
155 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890676 | DISPOSABLE TRANSDUCER MANIFOLD | L.O.N. Research, Inc. | 1989-07-14 | 155 | 0 |
| K880158 | ANGIOPLASTY BALLOON INFLATION DEVICE | L.O.N. Research, Inc. | 1988-03-22 | 69 | 0 |
| K853099 | L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION | L.O.N. Research, Inc. | 1985-12-03 | 133 | 0 |
| K812408 | L.O.N. DISPOSABLE CORONARY MANIFOLD | L.O.N. Research, Inc. | 1981-12-02 | 103 | 0 |
| K812407 | L.O.N. REUSABLE MANIFOLDS & STOPCOCKS | L.O.N. Research, Inc. | 1981-12-02 | 103 | 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