510(k) Report

FDA applicant

Surmodics,Inc.

Eden Prairie, MN12 decisions2018–20250 recalls

FDA records 12 decisions for Surmodics,Inc. (Eden Prairie, MN) from 2018 to 2025: 11 510(k) clearances and 1 original PMA approval. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 70 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 7 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 Surmodics,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12020: 12021: 12022: 22023: 42024: 12025: 1
2018high 4 (2023) · low 1 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Surmodics,Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surmodics,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration5decisions
  • DYBIntroducer, Catheter3decisions
  • DQYCatheter, Percutaneous3decisions
  • ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 70 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 74 days; 5 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 20232cite it
  • K220501Pounce Thrombectomy SystemSurmodics,Inc. · 20222cite it
  • K231828Pounce™ SheathSurmodics,Inc. · 20231cites it
  • K192814Pounce Thrombus Retrieval SystemSurmodics,Inc. · 20201cites it
  • K173560MicrocatheterSurmodics,Inc. · 20181cites it
  • K211492Pounce Thrombectomy SystemSurmodics,Inc. · 20211cites it

What has FDA decided for it lately?

  • K252227Pounce (TM) SheathSurmodics,Inc. · 2025
  • K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc. · 2024
  • K232647MicrocatheterSurmodics,Inc. · 2023
  • K231828Pounce™ SheathSurmodics,Inc. · 2023
  • P210025SurVeil Drug-Coated BalloonSurmodics,Inc. · 2023
  • K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023
  • K221886Sublime MicrocatheterSurmodics,Inc. · 2022
  • K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022

All 12 as Surmodics,Inc. →