510(k) Report

FDA applicant

Memory MD, Inc.

New York, NY3 decisions2018–20210 recalls

FDA records 3 decisions for Memory MD, Inc. (New York, NY) from 2018 to 2021: 3 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GWQ (Full-Montage Standard Electroencephalograph). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No 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, neurology panel, where it files most

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

FDA decisions per year

1in 2021

2018: 22021: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Memory MD, 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?

  • GXYElectrode, Cutaneous2decisions
  • GWQFull-Montage Standard Electroencephalograph1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 157 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K172866NeuroCapMemory MD, Inc. · 20181cites it

What has FDA decided for it lately?

  • K202913NeuroCap (Model DEC22)Memory MD, Inc. · 2021
  • K172866NeuroCapMemory MD, Inc. · 2018
  • K173460NeuroEEGMemory MD, Inc. · 2018

All 3 as Memory MD, Inc. →