Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

PLA — Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

140 daysmedian FDA review time
410 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250632Arctx Cool Catheter SetArctx Medical2025-10-302410
K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.2024-06-272720
K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical2018-05-17560
K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical2018-02-28300
K172029EnsoETMAttune Medical2018-01-051840
K172493EnsoETMAttune Medical2017-10-17600
K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC2017-03-30860
K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC2016-01-151400
DEN140018ESOPHAGEAL COOLING DEVICEAdvanced Cooling Therapy, LLC2015-06-234100

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