# K983194: Sporicidin Sterilizing and Disinfecting Solution (SSDS)

- Pathway: 510(k) (Traditional)
- Applicant: Sporicidin Intl.
- Decided: Mar 5, 1999 after 175 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CIDEX® Activated Dialdehyde Solution: named in the summary without a submission number

## Indications for use
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices. Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions: Sterilization: 12 hours at 25 degrees C High Level Disinfection: 20 minutes at 25 degrees C SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%. Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.

Source page: https://510kreport.com/device/K983194
Methodology: https://510kreport.com/methodology