510(k) Report

FDA applicant

Ninepoint Medical, Inc.

Bedford, MA8 decisions2011–20191 recall

FDA records 8 decisions for Ninepoint Medical, Inc. (Bedford, MA) from 2011 to 2019: 8 510(k) clearances. All are in product code NQQ (System, Imaging, Optical Coherence Tomography…). Its devices cite 13 predicates, 7 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Ninepoint Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2011: 12012: 12013: 12015: 12016: 12018: 22019: 1
2011high 2 (2018) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2011high 1 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ninepoint Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ninepoint 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?

  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)8decisions

Whose devices does it build on?

Its devices cite 13 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 20113cite it
  • K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 20152cite it
  • K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm…Ninepoint Medical, Inc. · 20161cites it
  • K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 20181cites it
  • K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 20131cites it
  • K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 20181cites it

What has FDA decided for it lately?

  • K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. · 2019
  • K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc. · 2018
  • K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc. · 2018
  • K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm…Ninepoint Medical, Inc. · 2016
  • K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc. · 20151 recall
  • K120800Nvision Vle Imaging SystemNinepoint Medical, Inc. · 2013
  • K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc. · 2012
  • K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc. · 2011

All 8 as Ninepoint Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143678NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI…Apr 11, 2018Class II