Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lawrence Medical Systems, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874492 | LAWRENCE L4000 REFLECTANCE PULSE OXIMETER | Lawrence Medical Systems, Inc. | 1988-03-22 | 141 | 0 |
| K874885 | LAWRENCE L3000 CARDIAC OUTPUT MONITOR | Lawrence Medical Systems, Inc. | 1988-02-05 | 66 | 0 |
| K862548 | TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER | Lawrence Medical Systems, Inc. | 1986-10-22 | 111 | 0 |
| K851426 | ACCUCOM CARDIAC OUTPUT MONITOR | Lawrence Medical Systems, Inc. | 1985-07-12 | 93 | 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