# K972708: Endo-Spor Plus / Hyprocide

- Pathway: 510(k) (Traditional)
- Applicant: Cottrell, Ltd.
- Decided: Sep 13, 1999 after 784 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875280 (1988). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932922: Procide 14 N.S., Omnicide/Liquid & Plus Liq Activator, Cottrell, Ltd. (1995) Summary page 1.
- K923744: Cidex Plus 28 Day Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 1.
- K924334: Cidex Formula 7* Long-Life Activated Dialdehyde, Johnson & Johnson Medical, Inc. (1994) Summary page 1.
- K924434: Cidex Activated Dialdehyde Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 1.
- K875280: Steris System 1 Processor and 20 Sterilant, Steris C/O Medical Device Consultants, Inc. (1988). Our OCR of the scanned summary read K875250, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## Most influential descendants
- K013280: Sterilox Liquid Chemical Sterilant System (2002), 6 descendants of its own
- K090036: System 1.5 Sterile Processing System (2010), 4 descendants of its own
- K101409: System IE Liquid Chemical Cterilant Processing System (2010), 3 descendants of its own
- K102462: System 1E Liquid Chemical Sterilant Processing System (2010), 2 descendants of its own
- K113520: System 1E Liquid Chemical Sterilant Processing System (2012), 1 descendant of its own

## Indications for use
Endo-Spor Plus™/Hyprocide™ is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.

Source page: https://510kreport.com/device/K972708
Methodology: https://510kreport.com/methodology