Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Webster Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
170 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853383 | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN | Webster Laboratories, Inc. | 1985-12-03 | 113 | 0 |
| K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE | Webster Laboratories, Inc. | 1984-10-18 | 170 | 0 |
| K834602 | SWITCHING UNIT ELECTRODE CATHETER | Webster Laboratories, Inc. | 1984-05-09 | 131 | 0 |
| K823361 | SWITCHING UNIT ELECTRODE CATHETERS | Webster Laboratories, Inc. | 1983-01-14 | 66 | 0 |
| K813271 | TEMPERATURE PROBES | Webster Laboratories, Inc. | 1981-12-29 | 39 | 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