FDA applicant

Core-M, Inc.

Allston, MA4 decisions1989–19960 recalls

FDA records 4 decisions for Core-M, Inc. (Allston, MA) from 1989 to 1996: 4 510(k) clearances. Most are in product codes CAP (Monitor, Airway Pressure (Includes Gauge…) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). No recall is linked to its devices.

FDA’s records also spell it “Core-M, L.P.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Core-M, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Core-M, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Core-M, 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

Other applicant names beginning “Core-M”

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

Core-Vent Corp. 25 Core Dynamics, Inc. 23 Core Essence Orthopaedics, LLC 6 Core Medical, Inc. 3 Core-Nexus 2 Core-Vent Bio-Engineering, Inc. 1 Core 3D Protech, S.L. 1 Core Healthcare, Ltd. 1 Core Access Surgical Technologies, Inc. 1 Core Scientific, Ltd. 1 Core Scientific Creation, Ltd. 1

Core-M, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Core-M”