FDA applicant

Aspect Medical Systems, Inc.

Newton, MA25 decisions1992–20092 recalls

FDA records 25 decisions for Aspect Medical Systems, Inc. (Newton, MA) from 1992 to 2009: 25 510(k) clearances. Most are in product codes OLW (Index-Generating Electroencephalograph Software) and GXY (Electrode, Cutaneous). Its devices cite 29 predicates, 27 of them its own earlier devices. 2 recalls are 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 Aspect Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Aspect Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aspect Medical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Aspect”

FDA records each applicant name separately; these may or may not be the same firm.

Aspect Imaging, Ltd. 6 Aspect Vision Care, Ltd. 5 Aspect Electronics, Inc. 3

Aspect Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Aspect”