# K140589: Sterrad Cyclesure 24 Plus Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Mesa Laboratories, Inc.
- Decided: Dec 3, 2014 after 271 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (2019), 2 descendants of its own
- K233814: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader  (490); 3M™ Attest™ Auto-reader  (490H); 3M™ Attest™ Mini Auto-reader  (490M) (2024), 1 descendant of its own
- K241542: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (2024), 0 descendants of its own

## Indications for use
The STERRAD® CYCLESURE® 24 PLUS Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilizer Systems used in Healthcare facilities: STERRAD® 50 STERRAD® 100S STERRAD® 200 STERRAD® NX Standard Cycle STERRAD® NX Advanced Cycle STERRAD® 100NX STANDARD Cycle STERRAD® 100NX FLEX Cycle STERRAD® 100NX DUO Cycle STERRAD® 100NX EXPRESS Cycle

Source page: https://510kreport.com/device/K140589
Methodology: https://510kreport.com/methodology