510(k) · Cleared
ClearedSteriTite Containers 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 Feb 10, 2017 as substantially equivalent to K090068 (Case Medical, Inc., 2010) and 5 other predicates after a 263-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Feb 10, 2017
- Review
- 263 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K040865 (2004). 8 ancestors in all, the oldest K991023 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
- 2 generations backK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
- 1 generation backK110682 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011
- This deviceK161415 SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040865 | Aesculap Sterrad 100S Compatable Sterilcontainer | Aesculap | 2004 | — |
| −2 | K093493 | Aesculap Sterilcontainer S | Aesculap, Inc. | 2010 | — |
| −1 | K110682 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2011 | — |
| 0 (this device) | K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (6)
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 |
|---|---|---|---|
| * | K090068 | Steritite Universal Container System and Meditray ProductsSummary page 5…terilizer (Cycle 1)is substantially equivalent to the SteriTite® container system, previously cleared for: • Amsco V-PRO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682… | 2010 |
| * | K112904 | Steritec Containers System & Meditray ProductsSummary page 5…(Cycle 1)is substantially equivalent to the SteriTite® container system, previously cleared for: • Amsco V-PRO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682 •… | 2012 |
| * | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 -…Summary page 5…iously cleared for: • Amsco V-PRO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682 • TSO3 Ozone 125L sterilizers - 510(k) K080558 5.2 Description of the Device… | 2000 |
| * | K030853 | Steritite Perforated Base Rigid Reusable Sterilization Container System with…Summary page 5…eared for: • Amsco V-PRO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682 • TSO3 Ozone 125L sterilizers - 510(k) K080558 5.2 Description of the Device: The St… | 2003 |
| * | K080558 | Steritite Container System & Meditray ProductsSummary page 5…: • Amsco V-PRO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682 • TSO3 Ozone 125L sterilizers - 510(k) K080558 5.2 Description of the Device: The SteriTite®… | 2008 |
| * | K110682 | Steritite Container System & Meditray ProductsSummary page 5…RO hydrogen peroxide sterilizer - 510(k) K090068& K112904 • STERRAD hydrogen peroxide gas plasma sterilizers - 510(k) K991023, K030853, K080558 and K110682 • TSO3 Ozone 125L sterilizers - 510(k) K080558 5.2 Description of the Device: The SteriTite® container system consist… | 2011 |
| † | K153689 | STERIZONE Sterilizer | 2016 |
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 13 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K090068.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® 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 container consists of a solid or perforated base and perforated lid with filter retention plates, and disposable polypropylene filters. The Case Medical’s SteriTite® container system and MediTray products are compatible with the TSO3 Inc.’s STERIZONE® VP4 Cycle 1 sterilization system for blades, lumened devices and flexible endoscopes.
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/K161415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161415: SteriTite Containers System & MediTray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161415
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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