FDA applicant

Engineered Custom Mfg., Inc.

Ridgefield, NJ1 decision1997–19971 recall

FDA records 1 decision for Engineered Custom Mfg., Inc. (Ridgefield, NJ) in 1997: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Engineered Custom Mfg., Inc. since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Engineered Custom Mfg., 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 “Engineered”

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

Engineered Medical Systems 24 Engineered Medical Solutions Co., LLC 2 Engineered Orthopedic Technologies, Inc. 2 Engineered Medical Technology, Inc. 1 Engineered Tissue Solutions, LLC 1 Engineered Endodontics 1

Engineered Custom Mfg., 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?

What has been recalled?

Other applicant names beginning “Engineered”