# K192056: JJ Series Container System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 27, 2020 after 239 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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: 5 generations back to K871202 (1987). 13 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112671: Sterilcontainer System, Aesculap, Ltd. (2012) Summary page 12.

## Most influential descendants
- K214041: Aesculap AICON Container (2022), 4 descendants of its own
- K242762: Aesculap Aicon® Series Container System (2025), 0 descendants of its own
- K250029: ONE TRAY® Sealed Sterilization Container System (2025), 0 descendants of its own
- K242834: System 9 Sterile Battery Container (2025), 0 descendants of its own
- K233578: Bahadir Sterilization Containers (2024), 0 descendants of its own

## Indications for use
The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below. The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container. The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. The attached tables identifies the load configurations. Table 1. JJ Series Container System Lumen Configurations Sterilization Cycle | Size | Lumens PreVac Steam with dry time (270°F 4 min Exposure) | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L PreVac Steam with dry time (270°F 4 min Exposure) | Three-Quarter Size | 4 stainless steel lumens with > 1mm ID x <400mm L PreVac Steam with dry time (270°F 4 min Exposure) | Half Size | 4 stainless steel lumens with > 1mm ID x <200mm L Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Full Size | Non lumened instruments Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Three-Quarter Size | Non lumened instruments Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Half Size | Non lumened instruments Prevac Steam without dry time (270°F 4 min Exposure) Porous | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L Prevac Steam without dry time (270°F 4 min Exposure) Porous | Three-Quarter Size | 4 stainless steel lumens with > 1mm ID x <400mm L Prevac Steam without dry time (270°F 4 min Exposure) Porous | Half Size | 4 stainless steel lumens with > 1mm ID x <125mm L Validation testing was performed using the JJ612 single use paper filter. Table 2. JJ Series Container System Configurations, Without Silicone Mat and Lid cover* [Configurations of solid bottom and EDS containers for Prevac Steam cycles, including the listed container bottom and lid part numbers, maximum load weights, and specified exposure and dry times.] Table 3. JJ Series Container System Configurations, with Silicone Mat and Lid Cover* [Configurations of solid bottom and EDS containers for Prevac Steam cycles, including the listed container bottom and lid part numbers, maximum load weights, and specified exposure and dry times.] *Dry times and load weights are based on container with silicone mats and/or lid cover. Table 4: Sterilization Cycle Compatible Accessories - Prevac Steam Accessories | Prevac Steam with dry time | Prevac Steam Without dry time Baskets, trays, indicator cards, tamper evident locks, faceplate holders, and tags. | Yes | Yes Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes Silicone mats | Yes1 | Yes Lid Covers | Yes1 | Yes 1 Using silicone mats and/or lid covers may require a longer drying time. When used with PreVac Steam with dry time (270°F, 4 minute exposure), the maintenance of sterility of the Aesculap JJ Series Container System is 365 days.

Source page: https://510kreport.com/device/K192056
Methodology: https://510kreport.com/methodology