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FDA 510(k)

PRIMUS Healthcare Sterilizer (Model PSS11-HC)

K-Number: K221474 · 2023-02-10

ApplicantPrimus Sterilizer Company, LLC
Decision Date2023-02-10
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is a medical device manufactured by Primus Sterilizer Company, LLC. It received FDA 510(k) clearance on 2023-02-10 under approval number K221474. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Primus Sterilizer Company, LLC. The 510(k) number is K221474.

When was PRIMUS Healthcare Sterilizer (Model PSS11-HC) approved by the FDA?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) received FDA 510(k) clearance on 2023-02-10, under approval number K221474.

What company makes PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is manufactured by Primus Sterilizer Company, LLC.

What is the FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

The FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC) is FLE.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 40678717 Bridging AI innovation and healthcare: scalable clinical validation methods for voice biomarkers. Frontiers in digital health (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Primus Sterilizer Company, LLC

K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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