FDA applicant

Instylla, Inc.

Bedford, MA11 decisions2019–20260 recalls

FDA records 11 decisions for Instylla, Inc. (Bedford, MA) from 2019 to 2026: 10 510(k) clearances and 1 original PMA approval. Most are in product codes FMF (Syringe, Piston) and KRA (Catheter, Continuous Flush). Since 2016 its 510(k)s took a median of 38 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 9 of them its own earlier devices. 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 Instylla, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2019high 3 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Instylla, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Instylla, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?