510(k) Report

FDA applicant

Alembic, LLC

Mountain View, CA13 decisions2023–20260 recalls

FDA records 13 decisions for Alembic, LLC (Mountain View, CA) from 2023 to 2026: 13 510(k) clearances. Most are in product codes NRY (Catheter, Thrombus Retriever) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 12 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 Alembic, LLC’s devices, and how often a recall has named them.

FDA decisions per year

6in 2025

2023: 22024: 22025: 62026 (partial year): 3
2023high 6 (2025) · low 2 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

Planning a device like Alembic, LLC’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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Which product codes does it file in?

  • NRYCatheter, Thrombus Retriever7decisions
  • DQYCatheter, Percutaneous4decisions
  • QJPCatheter, Percutaneous, Neurovasculature2decisions

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 12 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 9 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.

  • K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 20243cite it
  • K234115APRO 55 CatheterAlembic, LLC · 20243cite it
  • K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC · 20231cites it
  • K251014APRO 45 CatheterAlembic, LLC · 20251cites it
  • K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 20251cites it

What has FDA decided for it lately?

  • K261938APRO 88 CatheterAlembic, LLC · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2026
  • K251014APRO 45 CatheterAlembic, LLC · 2025
  • K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
  • K250962APRO 55 Intermediate CatheterAlembic, LLC · 2025
  • K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
  • K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025

All 13 as Alembic, LLC →