Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cs Medical, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
229 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Lev | Cs Medical, LLC | 2023-11-21 | 57 | 0 |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with Aq | Cs Medical, LLC | 2023-06-07 | 114 | 0 |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfec | Cs Medical, LLC | 2020-04-01 | 229 | 0 |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEE | Cs Medical, LLC | 2019-04-12 | 179 | 0 |
| K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level | Cs Medical, LLC | 2016-11-03 | 213 | 0 |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL T | Cs Medical, LLC | 2005-08-18 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda