Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 15 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Asahi Kasei and its 15 subsidiaries with 204 510(k) clearances, 60 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Oct 30, 2026: PolySense.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 265, 16 entities
510(k) clearances: 204
Device recalls: 60
Warning letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Asahi Kasei and its 15 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
52017Records5
720182018Records7vs 2017+2
42019Records4vs 2018−3
120202020Records1vs 2019−3
302021Records30vs 2020+29
520222022Records5vs 2021−25
42023Records4vs 2022−1
520242024Records5vs 2023+1
132025Records13vs 2024+8
520262026 to dateRecords5
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
