FDA applicant

Sarstedt, Inc.

Newton, NC7 decisions1992–20230 recalls

FDA records 7 decisions for Sarstedt, Inc. (Newton, NC) from 1992 to 2023: 7 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FMK (Single Use Only Blood Lancet With An Integral…). No recall is linked to its devices.

FDA’s records also spell it “Sarstedt AG & CO KG”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Sarstedt, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Sarstedt, Inc.

Which product codes does it file in?

What has FDA decided for it lately?