FDA applicant

Narco Bio-Systems

Mchenry, IL9 decisions1976–19860 recalls

FDA records 9 decisions for Narco Bio-Systems (Mchenry, IL) from 1976 to 1986: 9 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Narco Bio-Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Narco Bio-Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Narco Bio-Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Narco Bio-Systems’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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Other applicant names beginning “Narco”

FDA records each applicant name separately; these may or may not be the same firm.

Narco Scientific 31 Narco Air-Shields 19 Narco Mckesson Co. 6

Narco Bio-Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Narco”