FDA.reportPublic FDA data

510(k) K234082

Device
STERRAD® 100NX Sterilizer with ALLClear? Technology and ULTRA GI? Cycle (10104); APTIMAX? Instrument Tray for ULTRA GI? Cycle (011077)
Applicant
Advanced Sterilization Products
510(k) number
K234082
Product code
MLR
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-05
Date received
2023-12-22
Regulation
880.6860
Classification name
Sterilizer, Chemical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ayse Erkan
Address
33 Technology Dr. Irvin CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MLR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.2026-04-15
K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.2025-04-14
K231893LOWTEM Crystal 120Lowtem Co., Ltd.2024-09-18
K233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.2024-06-27
K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris2023-10-20
K223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation2023-08-07
K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co,., Ltd.2023-05-25
K223015STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassettePlasmapp Co,., Ltd.2023-05-09
K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co,., Ltd.2023-04-14
K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemSteris2022-09-09
K220404STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc.2022-05-16
K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd.2021-10-22
K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.2021-10-09
K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc.2019-09-13
K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization SystemsSTERIS Corporation2019-05-09