# K972138: Carr Rigid Container System

- Pathway: 510(k) (Traditional)
- Applicant: Carr Metal Products, Inc.
- Decided: Nov 13, 1997 after 160 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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 K792558 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 1.
- K833343: Sterilization Container, Medin Corp. (1983) Summary page 1.
- K844672: Instrutainer, Intrumed, Inc. (1985) Summary page 3.
- K871202: Flashpak Container System, Performance Instruments Corp. (1987) Summary page 1.

## Indications for use
Container system designed to contain medical and dental (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Pre-vacuum steam and EO sterilization. Sterility assurance tested up to 30 days.

Source page: https://510kreport.com/device/K972138
Methodology: https://510kreport.com/methodology