510(k) · Cleared
Recalled · Class III · 2013Steritite Rigid Reusable Sterilization Container System
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 Apr 7, 2003 as substantially equivalent to K012931 (Allegiance Healthcare Corp., 2002) after a 161-day review. Its family tree reaches back 2 generations to 2000. 9 later devices descend from it. It has been recalled once.
- Decided
- Apr 7, 2003
- Review
- 161 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991023 (2000). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 1 generation backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- This deviceK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- Descendant · 2 generations on · 6 of its ownK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- Descendant · 2 generations on · 3 of its ownK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K050570Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005 · cites it directly7descendants
- K091720Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010 · 2 generations on6descendants
- K102146Bahadir Sterilization TraysBahadir USA Corp. · 2010 · 2 generations on3descendants
- K112090Bahadir Sterilization TraysBahadir USA Corp. · 2012 · 3 generations on2descendants
- K131407Bahadir Sterilization TraysBahadir USA Corp. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −1 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| 0 (this device) | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | — |
| +1 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| +2 | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| +2 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| +3 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| +3 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | 2002 |
What descends from it? (9)
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)
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050570 (Miltex, Inc., 2005) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K012931.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 and MediTray product is intended to be used to contain medical devices for sterilization, storage,
transportation and aseptic presentation of contents in health care facilities. This includes sterilization of surfaces and lumened dev
in EO, Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mrn diameter or
larger and length up to 40 cm were validated. The SteriTite container is designed to maintain sterility of the contents until it is used
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023614: Steritite Rigid Reusable Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023614
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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