FDA applicant

Prism Enterprises, Inc.

Washington, DC4 decisions2000–20034 recalls

FDA records 4 decisions for Prism Enterprises, Inc. (Washington, DC) from 2000 to 2003: 4 510(k) clearances. Most are in product codes HDB (Extractor, Vacuum, Fetal) and FPP (Stretcher, Hand-Carried). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Prism Enterprises, Inc. since 2007.

Recalls per year

3in 2008

2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Prism Enterprises, 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 “Prism”

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

Prism Technologies, Inc. 5 Prism Imaging, Inc. 4 Prism Clinical Imaging, Inc. 2 Prism Therapeutics, LLC 1 Prism Surgical Design Pty, Ltd. 1 Prism Surgical Designs Pty, Ltd. 1

Prism Enterprises, 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 “Prism”