FDA applicant

Standard Textile Co., Inc.

Cincinnati, OH23 decisions1986–20240 recalls

FDA records 23 decisions for Standard Textile Co., Inc. (Cincinnati, OH) from 1986 to 2024: 23 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 7 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Standard Textile Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Standard Textile Co., Inc.’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 Bariatrics 12 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 Textile Co., Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Standard”