Class Class II

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802)

K250802 2025-04-14 Traditional
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Description

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) by Advanced Sterilization Products, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250802
Clearance Date2025-04-14
Clearance TypeTraditional
Product CodeMLR
Regulation Number880.6860

Categories

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Predicate lineage for K250802

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULT...Advanced Sterilization Products2024

Trace the full predicate network for K250802

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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