FDA applicant

Pressure Products Medical Device Manufacturing, LLC

Morton, PA9 decisions2017–20261 recall

FDA records 9 decisions for Pressure Products Medical Device Manufacturing, LLC (Morton, PA) from 2017 to 2026: 9 510(k) clearances. Most are in product codes DRC (Trocar) and DXF (Catheter, Septostomy). Its devices cite 9 predicates, 3 of them its own earlier devices. 1 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, cardiovascular panel, where it files most

How often FDA has decided Pressure Products Medical Device Manufacturing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2022

2017high 1 (2022) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Pressure Products Medical Device Manufacturing, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pressure Products Medical Device…’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 “Pressure”

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

Pressure-Tech, Inc. 1 Pressure Point, Inc. 1 Pressure Products, Inc. 1

Pressure Products Medical Device Manufacturing, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Pressure”