510(k) Report

510(k) · Cleared

Cleared

Aesculap Sterilcontainer S

K093649510(k) TraditionalCleared May 11, 2010167-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 · FRG Wrap, Sterilization

Cleared on May 11, 2010 as substantially equivalent to K040865 (Aesculap, 2004) after a 167-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.

Decided
May 11, 2010
Review
167 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040865 (2004). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant clearedK040865 · Aesculap Sterrad 100S Compatable Sterilcontainer · Aesculap · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K040865 · Aesculap Sterrad 100S Compatable Sterilcontainer · Aesculap · 20040
  1. Root · 1 generation backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
  2. This deviceK093649 Aesculap Sterilcontainer SAesculap · 2010
  3. Descendant · cites it directly · 2 of its ownK151242 SterilContainer SAesculap, Inc. · 2015
  4. Descendant · 2 generations on · 1 of its ownK162815 SterilContainer S SystemAesculap, Inc. · 2017
  5. Descendant · 3 generations on · 0 of its ownK193582 SterilContainer S2 SystemAesculap, Inc. · 2020
  6. Descendant · cites it directly · 0 of its ownK143729 SterilContainer SAesculap, Inc. · 2015

Most influential descendants

Showing 4 of 4 · See all
  • K151242SterilContainer SAesculap, Inc. · 2015 · cites it directly2descendants
  • K162815SterilContainer S SystemAesculap, Inc. · 2017 · 2 generations on1descendant
  • K193582SterilContainer S2 SystemAesculap, Inc. · 2020 · 3 generations on0descendants
  • K143729SterilContainer SAesculap, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040865Aesculap Sterrad 100S Compatable SterilcontainerAesculap2004—
0 (this device)K093649Aesculap Sterilcontainer SAesculap2010—
+1K151242SterilContainer SAesculap, Inc.2015—
+2K162815SterilContainer S SystemAesculap, Inc.2017—
+3K193582SterilContainer S2 SystemAesculap, Inc.2020—
+1K143729SterilContainer SAesculap, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201710
202010
FIG. 1 — Lineage of K093649, 2004–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FRG? 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 FRG device

  1. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040865Aesculap Sterrad 100S Compatable Sterilcontainer
Summary page 1
…ALENCE Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to: Aesculap STERRAD10OS Compatiaible Sterilcontainer (K040865). DEVICE DESCRIPTION The Aesculap Sterilcontainer S is designed as a container system that will allow for…
Aesculap2004—

Also cleared against K040865: 1 other device →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151242SterilContainer SAesculap, Inc.20152
K143729SterilContainer SAesculap, Inc.20150

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, K151242 (Aesculap, Inc., 2015) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K040865.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
2007high 22 (2018) · low 0 (2010)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The Aesculap Sterilcontainer S is a reusable 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 with the V-PRO 1 and V-PRO Plus Systems. The Sterilcontainer S is recommended for surface and lumens: * 1mm…

Read the full statement (133 words)

The Aesculap Sterilcontainer S is a reusable 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 with the V-PRO 1 and V-PRO Plus Systems.

The Sterilcontainer S is recommended for surface and lumens:

* 1mm internal diameter and < 125 mm in length

* 2mm internal diameter and < 250 mm in length

* 3mm internal diameter and < 400 mm in length

Lumen Cycle - The maximum number of lumens per load is 20 lumens.

The attached table identifies which Sterilcontainer S may be sterilized in the V-PRO 1 and V-PRO Plus Systems.

Indications for use as stated in the FDA summary.

Also cleared against K040865

1 other device cites the same predicate.

  • K093493Aesculap Sterilcontainer SAesculap, Inc. · 2010

More from Aesculap

10 FDA decisions under this applicant name. See the company

  • K062085S4 Spinal SystemAesculap · 2007
  • K062510Aesculap Sterilcontainer SystemAesculap · 2006
  • K061135Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019Aesculap · 2006
  • K043079Bicontact Hip System with U-CapAesculap · 2004
  • K040865Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K093649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093649: Aesculap Sterilcontainer S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093649

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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