# K974062: Medsci 3% Glutaraldehyde

- Pathway: 510(k) (Traditional)
- Applicant: Medsci, Inc.
- Decided: Sep 2, 1998 after 310 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 K923744 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923744: Cidex Plus 28 Day Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 1.

## Indications for use
MedSCl 3% glutaraldehyde may be used to sterilize or high-level disinfect reusable medical devices that are heat labile or otherwise incompatible with other biologically monitored methods of sterilization. MedSCi 3% glutaraldehyde is intended to be used by healthcare practitioners, e.g., doctors, nurses and dentists in various healthcare facilities, e.g., hospitals, doctors offices and dentist offices. Germicidal Level of Activity of MedSCl 3% glutaraldehyde as a: Staerilant. MedSCl 3% glutaraldehyde is a sterilant when reusable medical devices are immersed for 10 hours at 25°C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor. High-Level Disinfectant. MedSCl 3% glutaraldehyde is a high-level disinfectant when reusable medical devices are immersed for 25 minutes at 25° C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.

Source page: https://510kreport.com/device/K974062
Methodology: https://510kreport.com/methodology