FDA applicant

Access Pharmaceuticals, Inc.

Dallas, TX2 decisions2006–20140 recalls

FDA records 2 decisions for Access Pharmaceuticals, Inc. (Dallas, TX) from 2006 to 2014: 2 510(k) clearances. Most are in product codes OLR (Oral Wound Dressing) and PHN (Protective Coating, Mucoadhesive Application…). Its devices cite 3 predicates, 1 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

How often FDA has decided Access Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Access Pharmaceuticals, 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 “Access”

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

Access Scientific, Inc. 14 Access Surgical Intl., Inc. 9 Access Vascular, Inc. 9 Access / God Loves You 4 Access Point Medical, LLC 4 Access Bio Incorporate 4 Access Bio, Inc. 3 Access Devices, Inc. 3 Access Battery, Inc. 2 Access Radiology Corp. 2 Access Cardiosystems, Inc. 2 Access Point Technologies Ep, Inc. 1

Access Pharmaceuticals, Inc.

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?

Other applicant names beginning “Access”