Atlas FDA

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

QJU — Predicate Candidate Screening

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

163 daysmedian FDA review time
265 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260338ThinkSono GuidanceThinkSono GmbH2026-07-151630
K260780HeartFocusDeski2026-06-03850
K251416UltraSight GuidanceUltrasight , Ltd.2025-12-172240
K242807HeartFocus (V.1.1.1)Deski2025-04-041990
K243065Cardiac GuidanceCaption Health, Inc.2025-01-151100
K223347UltraSight AI GuidanceUltrasight, Inc.2023-07-242650
K201992Caption GuidanceCaption Health2020-09-18630
K200755Caption GuidanceCaption Health2020-04-16240
DEN190040Caption GuidanceBay Labs, Inc.2020-02-071640

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