510(k) Report

FDA applicant

View Point Medical, Inc.

Carlsbad, CA3 decisions2018–20240 recalls

FDA records 3 decisions for View Point Medical, Inc. (Carlsbad, CA) from 2018 to 2024: 3 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and GDW (Staple, Implantable). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “View Point 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 View Point Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like View Point Medical, 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?

  • NEUMarker, Radiographic, Implantable2decisions
  • GDWStaple, Implantable1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 149 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 149 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241762OneMarkView Point Medical · 2024
  • K190689SignalMark Breast MarkerView Point Medical, Inc. · 2019
  • K180175SignalMark Lung Biopsy Site MarkerView Point Medical, Inc. · 2018

All 2 as View Point Medical, Inc. →The one decision as View Point Medical →