Atlas FDA

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

Livanova Deutschland, GmbH · Predicate Candidate Screening

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

241 daysmedian FDA review time
301 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH2023-08-24231
K221373Essenz HLMLivanova Deutschland, GmbH2023-03-093010
K220635Heater-Cooler System 3TLivanova Deutschland, GmbH2022-11-162570
K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH2021-11-101350
K210130Stockert S5 SystemLivanova Deutschland, GmbH2021-04-05760
K202154B-CaptaLivanova Deutschland, GmbH2021-04-012410
K191402Heater-Cooler System 3TLivanova Deutschland, GmbH2020-02-252771

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