Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Companion Medical, Inc. · Predicate Candidate Screening

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

130 daysmedian FDA review time
355 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201337InPen SystemCompanion Medical, Inc.2020-06-18292
K190487InPen Dose CalculatorCompanion Medical, Inc.2020-02-183551
K192841InPen SystemCompanion Medical, Inc.2020-02-101301
K181327InPen Dose CalculatorCompanion Medical, Inc.2018-07-06490
K160629InPenCompanion Medical, Inc.2016-07-261411

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