510(k) Report

FDA applicant

Pasture Pharma Pte, Ltd.

Murrieta, CA3 decisions2009–20150 recalls

FDA records 3 decisions for Pasture Pharma Pte, Ltd. (Murrieta, CA) from 2009 to 2015: 3 510(k) clearances. Most are in product codes NZJ (Respirator, N95, For Use By The General Public…) and FXX (Mask, Surgical). 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Pasture Pharma Pte, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2009: 12015: 2
2009high 2 (2015) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Pasture Pharma Pte, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies1decision
  • FXXMask, Surgical1decision
  • MSHRespirator, Surgical1decision

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.

  • K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 20151cites it

What has FDA decided for it lately?

  • K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95…Pasture Pharma Pte, Ltd. · 2015
  • K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015
  • K083176Pasture, Models: F550, A520Pasture Pharma Pte, Ltd. · 2009

All 3 as Pasture Pharma Pte, Ltd. →