510(k) Report

FDA applicant

Acacia, Inc.

Loma Linda, CA17 decisions1979–20141 recall

FDA records 17 decisions for Acacia, Inc. (Loma Linda, CA) from 1979 to 2014: 17 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FMF (Syringe, Piston). Its devices cite 14 predicates, 0 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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2014

2009: 12010: 12012: 12013: 12014: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Acacia, Inc.’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 “Acacia”

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