Atlas FDA

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

Capsule Technologie Sas — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas2021-10-192660
K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas2020-07-101000
K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus LicCapsule Technologie Sas2017-10-241330
K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas2015-09-171490

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