510(k) Report

FDA applicant

Cutting Edge Technologies, Inc.

West Chester, PA2 decisions1995–19970 recalls

FDA records 2 decisions for Cutting Edge Technologies, Inc. (West Chester, PA) from 1995 to 1997: 2 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and KGX (Tape And Bandage, Adhesive). 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, general hospital panel, where it files most

How often FDA has decided Cutting Edge Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cutting Edge Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cutting Edge Technologies, 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 “Cutting”

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