Cs Medical, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cs Medical, LLC” (first 2005, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 148 days. Since 2017 the median was 146 days, against 206 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 213 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 179 |
| 2020 | 1 | 229 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 86 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cs Medical, LLC took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | 6 | 6 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Review panels
- General Hospital (6)
- Anesthesiology (2)
Most recent Cs Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | PSW | 2023-11-21 | 57 |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | PSW | 2023-06-07 | 114 |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | PSW | 2020-04-01 | 229 |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | PSW | 2019-04-12 | 179 |
| K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | PSW | 2016-11-03 | 213 |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | PSW | 2005-08-18 | 91 |
| K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM | BZR | 2005-07-13 | 148 |
| K050379 | CS MEDICAL ADULT TTCF CATHETER | BTO | 2005-07-12 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Cs Medical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cs Medical, LLC?
FDA lists 8 510(k) clearances under the applicant name “Cs Medical, LLC” (first 2005, latest 2023), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cs Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cs Medical, LLC is 148 days. Since 2017: 146 days, versus 206 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cs Medical, LLC?
The most frequent FDA product codes under this applicant name are PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid, 6); BTO (Tube, Tracheostomy (W/Wo Connector), 1); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 1).
Next steps
- See all 8 Cs Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code PSW, Cs Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.