510(k) Report

FDA applicant

Pmbs, LLC

Stockton, NJ2 decisions2015–20190 recalls

FDA records 2 decisions for Pmbs, LLC (Stockton, NJ) from 2015 to 2019: 2 510(k) clearances. All are in product code KCT (Sterilization Wrap Containers, Trays…). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2019

2015: 12019: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Pmbs, LLC 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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152014MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 20151cites it
  • K190541MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 20191cites it

What has FDA decided for it lately?

  • K190541MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019
  • K152014MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015

All 2 as Pmbs, LLC →