FDA applicant

Standard Bariatrics

Cincinnati, OH12 decisions2016–20230 recalls

FDA records 12 decisions for Standard Bariatrics (Cincinnati, OH) from 2016 to 2023: 12 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and KNT (Tubes, Gastrointestinal (And Accessories)). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Standard Bariatrics, 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 Standard Bariatrics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016high 3 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Standard Bariatrics by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Standard Bariatrics’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 “Standard”

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

Standard Textile Co., Inc. 23 Standard Imaging, Inc. 10 Standard Diagnostics, Inc. 3 Standard Welders Supply Co. 3 The Standard Co., Ltd. 2 Standard Surgical 1 Standard Engineering 1 Standard Scientific, Inc. 1

Standard Bariatrics

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Standard”