510(k) Report

FDA applicant

Mevion Medical Systems

Littleton, MA4 decisions2012–202614 recalls

FDA records 4 decisions for Mevion Medical Systems (Littleton, MA) from 2012 to 2026: 4 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 of them its own earlier devices. 14 recalls are linked to its devices.

FDA’s records also spell it “Mevion Medical Systems, Inc.”.

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 Mevion Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12017: 12025: 12026 (partial year): 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2022

2014: 22015: 12016: 52018: 22020: 32022: 1
2012high 5 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Mevion Medical Systems by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 165 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 190 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 20122cite it
  • K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 20171cites it
  • K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 20251cites it

What has FDA decided for it lately?

  • K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026
  • K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
  • K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 20175 recalls
  • K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 201212 recalls

All 2 as Mevion Medical Systems →All 2 as Mevion Medical Systems, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K120676Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)Feb 1, 2022Class II
  • K172848MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended…Oct 19, 2020Class II
  • K120676MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation…Jun 23, 2020Class II
  • K120676MEVION S250i, MEVION S250; Proton Radiation Treatment SystemMay 15, 2020Class II
  • K172848MEVION S250iOct 1, 2018Class II
  • K120676MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated…Jun 29, 2018Class II