510(k) · Cleared

Cleared

Aesculap® SterilContainer (TM) S2 System

K182414510(k) TraditionalCleared Jul 5, 2019304-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Jul 5, 2019 as substantially equivalent to K792558 (Aesculap Instruments Corp., 1979) after a 304-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.

Decided: Jul 5, 2019
Review: 304 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K792558 (1979). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK792558 Container SystemAesculap Instruments Corp. · 1979
This deviceK182414 Aesculap® SterilContainer (TM) S2 SystemAesculap, Inc. · 2019
Descendant · cites it directly · 0 of its ownK193582 SterilContainer S2 SystemAesculap, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K193582SterilContainer S2 SystemAesculap, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792558	Container System	Aesculap Instruments Corp.	1979	—
0 (this device)	K182414	Aesculap® SterilContainer (TM) S2 System	Aesculap, Inc.	2019	—
+1	K193582	SterilContainer S2 System	Aesculap, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K182414, 1979–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KCT device

#1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K792558	Container System Summary page 9 …erilization REGULATION NUMBER: 880.6850 PRODUCT CODE: KCT DEVICE CLASS: Class II Predicate Device Aesculap SterilContainer System (K792558) Reference Device Aesculap SterilContainer S (K093649) Aesculap SterilContainer S (K093493) DEVICE DESCRIPTION The Aesculap S…	Aesculap Instruments Corp.	1979	—
†	K093649	Aesculap Sterilcontainer S	Aesculap	2010	—
†	K093493	Aesculap Sterilcontainer S	Aesculap, Inc.	2010	—

Also cleared against K792558: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K193582	SterilContainer S2 System	Aesculap, Inc.	2020	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K193582 (Aesculap, Inc., 2020) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K792558.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · KCT

11in 2025

2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007high 236 (2012) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KCT

17in 2022

2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCT

50in 2025

2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	199	0	2
2008	6	182	0	8
2009	6	89	0	5
2010	12	202	1	3
2011	6	117	2	3
2012	10	236	0	2
2013	8	131	1	6
2014	11	169	1	5
2015	15	151	0	6
2016	12	182	3	16
2017	10	211	1	3
2018	15	192	0	22
2019	18	187	0	15
2020	14	134	0	66
2021	18	185	1	26
2022	11	137	17	8
2023	10	94	0	30
2024	8	106	0	18
2025	11	205	0	50
2026	9	122	0	—

What is it indicated for?

The Aesculap(R) SterilContainer™ S2 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 until used. This container system is compatible for use in the following sterilization modalities: • Dynamic-air removal steam (PreVac) (Exposure…

Read the full statement (166 words)

• Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time)

• Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)

• STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles

• STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.

The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

The attached table identifies the validated load configurations for each of the modalities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K182414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182414: Aesculap® SterilContainer (TM) S2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182414

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026