FDA applicant
Caldera Medical, Inc.
FDA records 24 decisions for Caldera Medical, Inc. (Agoura Hills, CA) from 2006 to 2023: 24 510(k) clearances. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and OTO (Mesh, Surgical, Synthetic, Urogynecologic, For…). Since 2016 its 510(k)s took a median of 228 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 15 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Caldera Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Caldera Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Caldera Medical, Inc.’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) Report