510(k) · Cleared
ClearedSteritite Universal Container System and 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 Feb 24, 2010 as substantially equivalent to K080558 (Case Medical, Inc., 2008) after a 411-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- Feb 24, 2010
- Review
- 411 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080558 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK080558 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2008 · Recalled
- This deviceK090068 Steritite Universal Container System and Meditray ProductsCase Medical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK112904 Steritec Containers System & Meditray ProductsCase Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK161415 SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080558 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2008 | 1 |
| 0 (this device) | K090068 | Steritite Universal Container System and Meditray Products | Case Medical, Inc. | 2010 | — |
| +1 | K112904 | Steritec Containers System & Meditray Products | Case Medical, Inc. | 2012 | — |
| +1 | K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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? (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 | Decided |
|---|---|---|---|
| * | K080558 | Steritite Container System & Meditray ProductsSummary page 1…General Hospital Legally Marketed Predicate: SteriTite universal container system previously cleared for STERRAD 200 and STERRAD NX, 5 10k # K080558 Indications for Use: The SteriTite universal container system with MediTray products is a reusable sterilization container sys… | 2008 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FRG devicesFRG 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
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 Sterilite 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 Sterilite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.
SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumnened instruments of 3mm diameter or largdr and a length up to 400 mm or shorter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090068: Steritite Universal Container System and Meditray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090068
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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