FDA applicant

Spartan Micro, Inc.

Fremont, CA4 decisions2018–20220 recalls

FDA records 4 decisions for Spartan Micro, Inc. (Fremont, CA) from 2018 to 2022: 4 510(k) clearances. Most are in product codes HCG (Device, Neurovascular Embolization) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spartan Micro”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2022

2018high 2 (2022) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Spartan Micro, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spartan Micro, 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 “Spartan”

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

Spartan Laboratories, Inc. 2 Spartan Healthcare Products Co. 2 Spartan Ultrasonics, Inc. 2 Spartan Bioscience, Inc. 1 Spartan Marketing Group 1

Spartan Micro, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Spartan”