FDA applicant

Monarch Labs, LLC

Irvine, CA2 decisions2007–20111 recall

FDA records 2 decisions for Monarch Labs, LLC (Irvine, CA) from 2007 to 2011: 2 510(k) clearances. All are in product code NQK (Maggots, Medical). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Monarch Labs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Monarch Labs, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Monarch”

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

Monarch Medical Technologies, LLC 6 Monarch Products, Inc. 2 The Monarch Company 1 Monarch Bioimplants GmbH 1 Monarch Medical 1

Monarch Labs, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Monarch”