# K172850: SterilContainer with PrimeLine Pro Lid

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Nov 17, 2017 after 58 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: 4 generations back to K871202 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073168: Aesculap Primeline Container LTD., Aesculap, Inc. (2008) Summary page 5.

## Indications for use
The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) 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 in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization) sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks. Table 1: Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid A combined maximum load validated for all container configurations is 25lbs. Sterilization Cycle Parameters: Immediate Use (Non porous), 270ºF Temp, 3 min. Exposure; No stacking recommended. Immediate Use (porous), 270ºF Temp, 4 min. Exposure; No stacking recommended. Prevacuum Dry Time Study, 270ºF Temp, 4min. Exposure, 30 min. Dry Time; Stacking should not exceed 16-18” height. Prevacuum Dry Time Study, 270ºF Temp, 4min. Exposure, 30 min. Dry Time; Stacking should not exceed 16-18” height. PrimeLine Pro Lid with JP050 – Lid Size: ½ size Lid (298 x281 x36), Art. No. JP121 – JP125; ¾ size Lid (465 x 281 x 36), Art. No. JP111 – JP115; Full size Lid (588 x 281 x 36), Art. No. JP101 – JP105. Solid Base to be used with Lid: JK340 (4-1/4 in height), JK341 (5-1/2 in height), JK342 (6 in height), JK344 (8 in height), JK346 (10-1/2 in height); JK740 (4-1/4 in height), JK741 (5-1/2 in height), JK742 (6 in height), JK744 (8 in height); JK440 (4-1/4 in height), JK441 (5-1/2 in height), JK442 (6 in height), JK444 (8 in height), JK446 (10-1/2 in height). Max No. of Lumens Lumen Configuration: Immediate Use – Non Porous: No lumens, a hinged device, and a knurled (irregular surface) device. Immediate Use – Porous: 1 SS lumen with 3mm I.D. x 400mm L and a hinged device. Perforated Base to be used with Lid: ½ size Lid: JN340 (4½ in height), JN341 (5½ in height), JN342 (6 in height), JN344 (8 in height), JN346 (10½ in height); ¾ size Lid: JN740 (4-1/4 in height), JN741 (5-1/2 in height), JN742 (6 in height), JN744 (8 in height); Full size Lid: JN440 (4-1/4 in height), JN441 (5-1/2 in height), JN442 (6 in height), JN444 (8 in height), JN446 (10-1/2 in height). Table 2: Steam and IUSS Cycle Compatible Accessories Stainless Steel baskets, basket lids, and dividers — Yes. Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) — Yes. Silicone mats — Yes. Stainless Steel racks, trays, holders, clamps, brackets, and platforms — Yes.

Source page: https://510kreport.com/device/K172850
Methodology: https://510kreport.com/methodology