Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRO-LITE Sterilization Tray

K-Number: K183402 · 2019-03-01

ApplicantSTERIS Corporation
Decision Date2019-03-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-LITE Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183402. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-LITE Sterilization Tray?

PRO-LITE Sterilization Tray is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is STERIS Corporation. The 510(k) number is K183402.

When did PRO-LITE Sterilization Tray receive FDA 510(k) clearance?

PRO-LITE Sterilization Tray received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183402.

Who is the listed applicant for PRO-LITE Sterilization Tray?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-LITE Sterilization Tray?

The FDA product code for PRO-LITE Sterilization Tray is KCT.

Other records listing STERIS Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

View all 139 devices →

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑