FDA applicant
S & M Instrument Co.
FDA records 4 decisions for S & M Instrument Co. (Doylestown, PA) from 1988 to 1995: 4 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and CAF (Nebulizer (Direct Patient Interface)). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided S & M Instrument Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for S & M Instrument Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like S & M Instrument Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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