FDA applicant

Custom Ultrasonics

Ivyland, PA6 decisions1984–20203 recalls

FDA records 6 decisions for Custom Ultrasonics (Ivyland, PA) from 1984 to 2020: 6 510(k) clearances. Most are in product codes FEB (Accessories, Cleaning, For Endoscope) and NVE (Washer, Cleaner, Automated, Endoscope). Its devices cite 2 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Custom Ultrasonics, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Custom Ultrasonics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Custom Ultrasonics’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 “Custom”

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

Custom Pack Reliability 21 Custom Spine, Inc. 14 Custom Medical Products, Ltd. 14 Custom Services Intl., Inc. 9 Custom Orthopaedic Solutions, Inc. 8 Custom Surgical Products, Inc. 4 Custom Optical Frames, Inc. 4 Custom Medical, Inc. 3 Custom Medical Devices Intl., Inc. 3 Custom Cardio Components 2 Custom Medical Plastics, Inc. 2 Custom Hospitals Products 1

Custom Ultrasonics

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 “Custom”