FDA 510(k)

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Número K: K252843 · 2026-04-15

RequerenteAdvanced Sterilization Products, Inc.

Data da decisão2026-04-15

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERRAD 100NX Sterilization System with ALLClear Technology (10104) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252843. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

STERRAD 100NX Sterilization System with ALLClear Technology (10104) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K252843.

When did STERRAD 100NX Sterilization System with ALLClear Technology (10104) receive FDA 510(k) clearance?

STERRAD 100NX Sterilization System with ALLClear Technology (10104) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252843.

Who is the listed applicant for STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

The FDA 510(k) record lists Advanced Sterilization Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

The FDA product code for STERRAD 100NX Sterilization System with ALLClear Technology (10104) is MLR.

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Outros registros que listam Advanced Sterilization Products, Inc. como candidato(a)

K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)K220404STERRAD NX with ALLClear Technology K212174STERRAD 100NX Sterilizer with ALLClear Technology

Dispositivos Relacionados (Código: MLR)

K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization Products K233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris K223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

Fonte oficial

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