FDA applicant

Blackwell Device Consulting

Catawba, NC1 decision2013–20130 recalls

FDA records 1 decision for Blackwell Device Consulting (Catawba, NC) in 2013: 1 510(k) clearance. All are in product code ELW (Material, Impression). 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, dental panel, where it files most

How often FDA has decided Blackwell Device Consulting’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Blackwell Device Consulting by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blackwell Device Consulting’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

Blackwell Device Consulting

Which product codes does it file in?

What has FDA decided for it lately?