# K151242: SterilContainer S

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Oct 9, 2015 after 151 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: 2 generations back to K040865 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093649: Aesculap Sterilcontainer S, Aesculap (2010) Summary page 8.

## Most influential descendants
- K162815: SterilContainer S System (2017), 1 descendant of its own
- K193582: SterilContainer S2 System (2020), 0 descendants of its own

## Indications for use
The SterilContainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) 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 until used. This container system is compatible for use with the V-PRO maX Low Temperature Sterilization System Flexible Cycle. Table 1: Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations Load Configuration 1: Two SterilContainer S containers each with a basket, mat, accessories and a flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and no additional load. The flexible endoscopes may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter; or two lumens: one lumen with an inside diameter of 1 mm or larger and length of 990 mm or shorter; the second lumen with an inside diameter of 1 mm or larger and length of 850 mm or shorter. Load Configuration 2: Two SterilContainer S containers, each with a basket, mat and accessories. The first SterilContainer S container holds a flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and no additional load. The flexible endoscopes may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter; or two lumens: one lumen with an inside diameter of 1 mm or larger and length of 990 mm or shorter; the second lumen with an inside diameter of 1 mm or larger and length of 850 mm or shorter. The second SterilContainer S container holds reusable metal and non-metal non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The total load weight validated was 24 lbs. The validation studies were conducted with a flexible endoscope in a SterilContainer S container with basket, silicone mat, accessories and light cord (if not integral to endoscope). Also included in the load was an additional SterilContainer S container with instruments for a total load weight of 24.0 lbs.

Source page: https://510kreport.com/device/K151242
Methodology: https://510kreport.com/methodology