510(k) · Cleared
Recalled · Class III · 2013Steritite Container System & Meditray Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Case Medical, Inc. · FRG Wrap, Sterilization
Cleared on Dec 5, 2008 after a 281-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2008
- Review
- 281 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK080558 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK090068 Steritite Universal Container System and Meditray ProductsCase Medical, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK112904 Steritec Containers System & Meditray ProductsCase Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK110682 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK182032 SterilContainer S SystemAesculap, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093493Aesculap Sterilcontainer SAesculap, Inc. · 2010 · cites it directly4descendants
- K090068Steritite Universal Container System and Meditray ProductsCase Medical, Inc. · 2010 · cites it directly2descendants
- K112904Steritec Containers System & Meditray ProductsCase Medical, Inc. · 2012 · 2 generations on1descendant
- K110682Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011 · cites it directly1descendant
- K182032SterilContainer S SystemAesculap, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080558 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2008 | — |
| +1 | K093493 | Aesculap Sterilcontainer S | Aesculap, Inc. | 2010 | — |
| +1 | K090068 | Steritite Universal Container System and Meditray Products | Case Medical, Inc. | 2010 | — |
| +2 | K112904 | Steritec Containers System & Meditray Products | Case Medical, Inc. | 2012 | — |
| +1 | K110682 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2011 | — |
| +2 | K182032 | SterilContainer S System | Aesculap, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
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 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | — | Case Medical's previously cleared SteriTite container system Named without a submission number | |
| * | — | Aesculap Sterilcontainer Named without a submission number | |
| * | — | Aesculap One Tray Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2013 | Class III | Z-0434-2014 | Device Design | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093493 (Aesculap, Inc., 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre- vacuum steam flash sterilization (270°F for 4 minutes). The container…
Read the full statement (256 words)
The SteriTite universal container system with MediTray products is a reusable
sterilization container system used to enclose other medical devices, which are
to be sterilized, transported and stored by a health care provider. The SteriTite
container system is intended for use in STERRAD 200, STERRAD NX and
Ozone 125L sterilizers, as well as the sealed containers are intended for pre-
vacuum steam flash sterilization (270°F for 4 minutes). The container may be
used for sterilization of medical devices including full instrument sets and mixed
loads.
SteriTite Sealed Container system is recommended for surface and lumens:
-In STERRAD® 200 Sterilization, process only stainless steel lumened
instruments of 3mm diameter or larger and a length up to 400 mm.
-In STERRAD NX standard cycle, process stainless steel lumened instruments of
2mm diameter or larger and up to 400 mm in length.
-In STERRAD NX advanced cycle, process stainless steel lumened instruments
of 1mm diameter or larger and up to 500 mm in length and porous lumens
(flexible endoscope) of 1mm diameter or larger and up to 850 mm in length.
-In -Pre-vacuum Steam Flash Sterilization, process stainless steel lumened
instruments of 2mm diameter or larger and a length of up to 400 mm as well as
porous lumens of 3mm diameter or larger and a length up to 400 mm.
-In Ozone 125L Sterilization, process stainless steel lumened instruments of
3mm diameter or larger and a length up to 470 mm.
The attached tables identify which products with disposable filter may be
sterilized in the respective sterilization cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080558 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080558: Steritite Container System & Meditray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080558
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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