Atlas FDA

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

PMC · Predicate Candidate Screening

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

126 daysmedian FDA review time
277 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited2025-11-251250
K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.2021-10-211570
K191166DigniCap DeltaDignitana, Inc.2019-06-26560
K173032Paxman Scalp CoolerPaxman Coolers Limited2018-06-072520
K170871DigniCap Scalp Cooling SystemDignitana AB2017-07-031020
K163484Paxman Scalp CoolerPaxman Coolers Limited2017-04-171260
DEN150010Dignitana AB DigniCap SystemDignitana AB2015-12-082770

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