510(k) Report

FDA applicant

Cs Medical, LLC

Creedmoor, NC8 decisions2005–20230 recalls

FDA records 8 decisions for Cs Medical, LLC (Creedmoor, NC) from 2005 to 2023: 8 510(k) clearances. Most are in product codes PSW (High Level Disinfection Reprocessing…) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 12 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cs Medical, Inc.”.

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 Cs Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2016: 12019: 12020: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cs Medical, LLC’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

Which product codes does it file in?

  • PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid6decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision
  • BTOTube, Tracheostomy (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant…Cs Medical, LLC · 20053cite it
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 20161cites it
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 20191cites it
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 20201cites it

What has FDA decided for it lately?

  • K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC · 2023
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and…Cs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 2019
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 2016
  • K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant…Cs Medical, LLC · 2005
  • K050381CS Medical TTCF Gas Delivery SystemCs Medical, Inc. · 2005
  • K050379CS Medical Adult TTCF CatheterCs Medical, Inc. · 2005

All 6 as Cs Medical, LLC →All 2 as Cs Medical, Inc. →