510(k) · Cleared

Cleared

SterilContainer S System

K182032510(k) TraditionalCleared Dec 21, 2018144-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 Dec 21, 2018 as substantially equivalent to K093493 (Aesculap, Inc., 2010) after a 144-day review. Its family tree reaches back 2 generations to 2004.

Decided: Dec 21, 2018
Review: 144 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K040865 (2004). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
1 generation backK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
This deviceK182032 SterilContainer S SystemAesculap, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K040865	Aesculap Sterrad 100S Compatable Sterilcontainer	Aesculap	2004	—
−1	K093493	Aesculap Sterilcontainer S	Aesculap, Inc.	2010	—
0 (this device)	K182032	SterilContainer S System	Aesculap, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K182032, 2004–2018Source: 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
*	K093493	Aesculap Sterilcontainer S Summary page 5 …CLASSIFICATION NAME: Sterilization Wrap REGULATION NUMBER: 21 CFR 880.6850 PRODUCT CODE: KCT DEVICE CLASS: Class II PREDICATE DEVICE K093493 - SterilContainer™ S System for use in STERRAD 200, STERRAD NX (STANDARD (Std.) & ADVANCED (Adv.) and STERRAD 100NX (Std. & FLEX)…	Aesculap, Inc.	2010	—
†	K142970	SterilContainer S System	Aesculap, Inc.	2015	—

Also cleared against K093493: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K093493.

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. 2018, 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?

Read the full statement (127 words)

The SterilContainer S System 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 flexible endoscopes and accessories, cables, and camera heads. 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 STERRAD 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.

Validation testing for event related sterility maintenance has been conducted for up to 365 days.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K182032 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182032: SterilContainer S System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182032

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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