510(k) Report

FDA applicant

Source Production and Equipment Co., Inc.

Saint Rose, LA4 decisions2015–20160 recalls

FDA records 4 decisions for Source Production and Equipment Co., Inc. (Saint Rose, LA) from 2015 to 2016: 4 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 49 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.

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 Source Production and Equipment Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2016

2015: 12016: 3
2015high 3 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Source Production and Equipment Co., Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 50 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 49 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc. · 2016
  • K161396SPEC Model M23Source Production and Equipment Co., Inc. · 2016
  • K161395SPEC Model M13Source Production and Equipment Co., Inc. · 2016
  • K150895SPEC Model M16Source Production and Equipment Co., Inc. · 2015

All 4 as Source Production and Equipment Co., Inc. →

Other applicant names beginning “Source”

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

Source-Ray, Inc. 8Source Production & Equipment Co., Inc. 3Source Scientific Systems, Inc. 2