FDA applicant
Tuttnauer Co., Ltd.
FDA records 10 decisions for Tuttnauer Co., Ltd. (Beit-Shemesh, IL) from 1984 to 2022: 10 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tuttnauer , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tuttnauer Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tuttnauer Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Tuttnauer”
FDA records each applicant name separately; these may or may not be the same firm.