Atlas FDA

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

Capsule Technologie — Predicate Candidate Screening

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

102 daysmedian FDA review time
141 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K183638SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie2019-04-171120
K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie2018-08-081410
K032142DATACAPTORCapsule Technologie2003-08-08252
K020197MODIFICATION TO DATACAPTORCapsule Technologie2002-02-21302
K013019DATACAPTORCapsule Technologie2001-12-181022

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