510(k) Report

FDA applicant

Threadstone, LLC

Millersville, MD5 decisions2023–20260 recalls

FDA records 5 decisions for Threadstone, LLC (Millersville, MD) from 2023 to 2026: 5 510(k) clearances. All are in product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2023: 12024: 22025: 12026 (partial year): 1
2023high 2 (2024) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Threadstone, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GATSuture, Nonabsorbable, Synthetic, Polyethylene5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 140 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230311HyperSutureThreadstone, LLC · 20234cite it
  • K242201HyperSuture White/Green Extension LineThreadstone, LLC · 20251cites it

What has FDA decided for it lately?

  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025
  • K241376HyperSuture All Blue Extension LineThreadstone, LLC · 2024
  • K234079HyperSuture Extension LineThreadstone, LLC · 2024
  • K230311HyperSutureThreadstone, LLC · 2023

All 5 as Threadstone, LLC →