# K143729: SterilContainer S

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Aug 18, 2015 after 232 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.
No later device cites it as a predicate yet.
0 of 3 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 6.

## 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. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. 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 60 Low Temperature Sterilization System’s Lumen, Non Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The SterilContainer S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization. V-PRO 60 Sterilizer Lumen Cycle Total Lid Bottom Description load.e d Intended Container Load container weight (1bs) JM440 Full Size 90mm (4 %")* 21.46 [ Lumened and non-lumened devices with : —— diffusion-restricted spaces such as the hinged JM489 | IM441 Full Size 120mm (5 A7) 21.46 portion of forceps and scissors IM442 Full Size 135mm (6)* 21.46 e Medical devices, including single, dual and : = triple channeled rigid and semi-rigid _IM740 % Size 90mm (4 14”)* 13.85 endoscopes, with the following configurations: IM789 | IM741 % Size 120mm (5 47)* 13.85 e single or dual lumen devices with stainless = lumen(s) that is (are} > 0.77 mm internal IM742 % Size 135mm (67)* 13.85 ~ diameter (ID) and < 410 mm length IM340 ¥ Size 90mm (4 %")* 13.85 s triple lumen devices with stainless steel lumens that are IM389 | JM341 Y% Size 120mm (5 '47)* 13.85 > [.2 mm ID and < 275 mm length IM342 % Size 135mm (67)* 13.85 2 1.8 mmID and <310 mm length L one Mini 73 > 2.8 mm ID and <317 mm length Mo20 | mo21 | FX OFE,)*T' mm 7.65 o] Mini 67mm IM174 1 ] - MI188 (2 9y 7.65 * The validation chamber load consisted of one container containing a basket and basket Iid, mat, accessories, 12 lumens, and metal and non-metal medical devices **The validation chamber load consisted of two containers containing a basket and basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of 15.30 1bs. Each container held six (6) lumens for a total of 12 total lumens per load. V-PRO 60 Sterilizer Non Lumen Cyele Total Lid Bottom Description 1oad'e d Intended Container Load container weight (Ibs) IM440 Full Size 90mm (4 Y47)* 20.0 IM489 44T | Full Size 120mm (5 %)% 200 IM442 Full Size 135mm (6™)* 20.0 IM740 ¥ Size 90mm (4 Y47)* 13.85 Non-lumened devices including IM789 miv7a1 % Size 120mm (5 %) 13.85 devices with stainless steel or IM742 % Size 135mm (6™)* 13.85 titanium diffusion-restricted spaces IM340 ¥ Size 90mm (4 %7)* 13.85 such as the hinged portion of forceps IM389 V1341 % Size 120mm (5 V&7)* 13.85 and scissors. IM342 Y, Size 135mm (67)* 13.85 IMO020 | JMO021 Extra Long Mini 73mm (37)** 7.64 IM174 | IM188 Mini 67mm (2 %”)** 7.64 * The validation chamber load consisted of one container with a basket and basket lid, mat, accessories, and metal and non- metal medical devices **The validation chamber load consisted of two containers with a basket and basket lid, mat, accessories, and metal and non- metal medical devices for a total chamber load weight of 15.30 Ibs. V-PRO 60 Sterilizer Flexible Cycle Total loaded Lid Bottom Description® container Intended Container Load weight (1bs) IM440 | Full Size 90mm (4 '4™) 21.46 One flexible surgical endoscope or M489 JM441 | Full Size 120mm (5 %7) 21.46 bronchoscope with a light cord (if not integral to the endoscope) and mat without any IM442 Full Size 135mm (6™) 21.46 | additional load. The flexible endoscopes may IM740 % Size 90mm (4 14”) 13.85 contain: IMT789 \TIN741 | % Size 120mm (5 %) 13.85 | e single or dual lumen devices with lumens IM742 % Size 135mm (67) 13.85 that are > 1 mm ID and < 990 mm length IM389 IN341 | v Size 120mm (5 %) 13.85 JM342 Y4 Size 135mm (67) 13.85 * The validation chamber load consisted of one container with a basket and lid, mat, accessories, three (3) 1 x 1000mm lumens, one flexible endoscope, and one light cable. V-PRO 60 Sterilizer Compatible SterilContainer S Accessories Accessories Y-PRO 60 Stainless Steel baskets, Yes basket lids, and dividers ) Instrument Organization Yes System (Silicone and Stainless Steel racks, brackets, holders, and clamps) Silicone mats Yes Stainless Steel racks, trays, Yes holders, clamps, brackets and platforms

Source page: https://510kreport.com/device/K143729
Methodology: https://510kreport.com/methodology