Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Starboard Medical, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE) | Starboard Medical, LLC | 2014-06-16 | 150 | 0 |
| K111050 | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL | Starboard Medical, LLC | 2012-04-12 | 363 | 0 |
| K111282 | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INS | Starboard Medical, LLC | 2011-08-11 | 97 | 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