Data / Medical devices / United States / Cenorin, LLC
Cenorin, LLC: FDA-registered device maker in Kent, WA, United States, 2 510(k) clearances
Cenorin, LLC is registered with the FDA (registration 3004153171) in Kent, WA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 9, 2019. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004153171
- Address
- 6324 S 199th Pl Ste 107, Kent, WA, United States, 98032
- Owner or operator
- CENORIN (9057829)
- Roles
- Manufacturer
- First device listed
- October 8, 2004
- Registered through
- 2027
- Brand names listed
- 50 SERIES: MODEL 150 DRYER, 50 SERIES: MODEL 150-1 DRYER, 50 SERIES: MODEL 150-2 DRYER, 50 SERIES: MODEL 350 DRYER, 50 SERIES: MODEL 350-1 DRYER, 50 SERIES: MODEL 350-2 DRYER, Cenorin 610 Washer-Pasteurizer/High Level Disinfector, Cenorin 610HT Washer-Pasteurizer/High Level Disinfector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pasteurization, Hot Water | LDS | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Drying | JRJ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2019 | K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | LDS | Substantially Equivalent | Cenorin, LLC | accessdata.fda.gov |
| April 17, 1981 | K810311 | STERI-VERS | LDS | Substantially Equivalent | The Hilrad Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | 80295 | Class II | Terminated | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteuriza | There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. | accessdata.fda.gov |
| June 7, 2017 | 77637 | Class II | Terminated | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices | Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. | accessdata.fda.gov |
| April 24, 2014 | 68237 | Class II | Terminated | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: | Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction. | accessdata.fda.gov |
| January 24, 2013 | 68580 | Class II | Terminated | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water. | accessdata.fda.gov |
| June 7, 2010 | 55802 | Not yet classified | Terminated | HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HL | The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately c | accessdata.fda.gov |
| December 21, 2006 | 37018 | Not yet classified | Terminated | ThermaSure Medical Device Drying Cabinet, series 130 | Potential for user to receive an electrical shock. | accessdata.fda.gov |
Compare with other makers
Updated September 9, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.