510(k) Report

FDA applicant

Synaptive Medical, Inc.

Toronto, CA10 decisions2014–20243 recalls

FDA records 10 decisions for Synaptive Medical, Inc. (Toronto, CA) from 2014 to 2024: 10 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices, 1 Class I.

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

FDA decisions per year

1in 2024

2014: 12015: 12016: 32018: 12019: 12020: 12023: 12024: 1
2014high 3 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2020

2015: 12018: 1, 1 Class I2020: 1
2014high 1 (2015) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Synaptive Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synaptive 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?

  • HAWNeurological Stereotaxic Instrument4decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • IZISystem, X-Ray, Angiographic1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 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.

  • K142024Brightmatter Navigation SystemSynaptive Medical, Inc. · 20154cite it
  • K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 20162cite it
  • K140337Brightmatter Planning SoftwareSynaptive Medical, Inc. · 20141cites it
  • K200327EvrySynaptive Medical, Inc. · 20201cites it

What has FDA decided for it lately?

  • K231986Modus IRSynaptive Medical, Inc. · 2024
  • K232981Synq Software Version 1.3Synaptive Medical, Inc. · 2023
  • K200327EvrySynaptive Medical, Inc. · 2020
  • K183325Modus NavSynaptive Medical, Inc. · 2019
  • K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc. · 2018
  • K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. · 2016
  • K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 20161 Class I recall
  • K153284Synaptive ImageDrive ProSynaptive Medical, Inc. · 20161 recall

All 10 as Synaptive Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K153284Synaptive ImageDrive ClinicalFeb 26, 2020Class II
  • K153281BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product…Oct 9, 2018Class I
  • K142024Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026.…Dec 4, 2015Class II