FDA applicant
Cas Medical Systems, Inc.
FDA records 32 decisions for Cas Medical Systems, Inc. (Branford, CT) from 1985 to 2019: 32 510(k) clearances. Most are in product codes MUD (Oximeter, Tissue Saturation) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 81 predicates, 27 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cas Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Cas Medical Systems, 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