510(k) Report

FDA applicant

Elucent Medical, Inc.

Eden Prairie, MN4 decisions2018–20261 recall

FDA records 4 decisions for Elucent Medical, Inc. (Eden Prairie, MN) from 2018 to 2026: 4 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Elucent Medical”.

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 Elucent Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 12024: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2018high 1 (2024) · low 0 (2018)2026

Class I Class II/III not classified

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

Planning a device like Elucent Medical, Inc.’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?

  • NEUMarker, Radiographic, Implantable3decisions
  • EOQBronchoscope (Flexible Or Rigid)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 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.

  • K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical · 2026
  • K233639SmartClip Secure Soft Tissue MarkerElucent Medical, Inc. · 2024
  • K183400EnVisio Navigation SytemElucent Medical, Inc. · 20191 recall
  • K180640SmartClip Soft Tissue MarkerElucent Medical, Inc. · 2018

All 3 as Elucent Medical, Inc. →The one decision as Elucent Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K183400EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product…Nov 18, 2024Class II