FDA applicant
Narco Air-Shields
FDA records 19 decisions for Narco Air-Shields (Mchenry, IL) from 1978 to 1982: 19 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and CBK (Ventilator, Continuous, Facility Use). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Narco Air-Shields’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Narco Air-Shields since 2007.
Recalls per year
1in 2007
Class I Class II/III not classified
Planning a device like Narco Air-Shields’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 “Narco”
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