Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Radiant Medical — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

60 daysmedian FDA review time
309 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071358REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMRadiant Medical2007-06-01170
K071008REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMRadiant Medical2007-05-09300
K063405REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMRadiant Medical2007-01-08600
K042388RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBERadiant Medical2004-10-28560
K024327SETPOINT ENDOVASCULAR TEMPERATURE PROBERadiant Medical2003-03-25890
K012512SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEMRadiant Medical2002-06-113090

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