510(k) Report

FDA applicant

Mick Radio-Nuclear Instruments, Inc.

Bronx, NY43 decisions1978–20238 recalls

FDA records 43 decisions for Mick Radio-Nuclear Instruments, Inc. (Bronx, NY) from 1978 to 2023: 43 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and IWJ (System, Applicator, Radionuclide, Manual). Its devices cite 44 predicates, 28 of them its own earlier devices. 8 recalls are linked to its devices.

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 Mick Radio-Nuclear Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012: 12015: 12016: 12020: 12023: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2012

2008: 12011: 22012: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mick Radio-Nuclear Instruments, 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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