510(k) Report

FDA applicant

Lunar Corp.

Madison, WI29 decisions1989–20001 recall

FDA records 29 decisions for Lunar Corp. (Madison, WI) from 1989 to 2000: 29 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and KPS (System, Tomography, Computed, Emission). Its devices cite 18 predicates, 13 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Lunar”.

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

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

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

FDA decisions per year

No FDA decision for Lunar Corp. since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Lunar Corp.’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 “Lunar”

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