510(k) Report

FDA applicant

Bartor Pharmacal Co., Inc.

Pomona, NY1 decision2009–20090 recalls

FDA records 1 decision for Bartor Pharmacal Co., Inc. (Pomona, NY) in 2009: 1 510(k) clearance. All are in product code LFD (Saliva, Artificial). Its devices cite 2 predicates, 0 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 Bartor Pharmacal Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Bartor Pharmacal Co., Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bartor Pharmacal 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

Which product codes does it file in?

  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091718NeutrasalBartor Pharmacal Co., Inc. · 20091cites it

What has FDA decided for it lately?

  • K091718NeutrasalBartor Pharmacal Co., Inc. · 2009

The one decision as Bartor Pharmacal Co., Inc. →