510(k) · Cleared
ClearedCase Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Case Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 13, 2018 as substantially equivalent to K022978 (Case Medical, Inc., 2003) after a 246-day review. Its family tree reaches back 2 generations to 1987. 4 later devices descend from it.
- Decided
- Jun 13, 2018
- Review
- 246 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871202 (1987). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 1 generation backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- This deviceK173259 Case Medical SteriTite Reusable Rigid Sterilization Container System…Case Medical, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK212711 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK240898 SteriTite rigid reusable sterilization container with MediTray…Case Medical · 2024
- Descendant · 3 generations on · 0 of its ownK252854 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221492 SteriTite Container System with MediTray PartsCase Medical, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K212711SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2022 · cites it directly3descendants
- K240898SteriTite rigid reusable sterilization container with MediTray ProductsCase Medical · 2024 · 2 generations on1descendant
- K252854SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026 · 3 generations on0descendants
- K221492SteriTite Container System with MediTray PartsCase Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −1 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| 0 (this device) | K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with… | Case Medical, Inc. | 2018 | — |
| +1 | K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2022 | — |
| +2 | K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024 | — |
| +3 | K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026 | — |
| +2 | K221492 | SteriTite Container System with MediTray Parts | Case Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 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 |
|---|---|---|---|
| * | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsSummary page 6…ss of Device: Class II Product Code: KCT Review Panel: General Hospital Establishment Registration Number: 2248608 Predicate device: K022978 - SteriTite Rigid sterilization Containerr System with FlashTite valve plate & MediTray Products 5.2 Descript… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212711 | SteriTite Container System with MediTray Products | 2022 | 3 |
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 31 years and passes through 2 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K212711 (Case Medical, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K022978.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The SteriTite® container system with MediTray® products is a rigid reusable sealed 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 a perforated base, perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use. The…
Read the full statement (1,038 words)
The SteriTite® container system with MediTray® products is a rigid reusable sealed 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 a perforated base, perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use.
The SteriTite® container has been validated for prevacuum sterilization at 132°C for 4 minutes. with 3 stainless steel (3mm inner diameter × 400mm length) and 3 porous lumens (2mm inner diameter × 400mm length), and representative products of the MediTray line of accessories such as: insert boxes, multilevel tray systems, instrument baskets (stacked and single level) with various inserts including brackets, posts, and partitions. The container may be used for sterilization of medical devices including full instrument sets, stacked trays, and mixed loads.
Additionally, the SteriTite® container has been validated for prevacuum sterilization at 134°C for 4 minutes using tabletop autoclaves for metal instrument loads with 5 stainless steel lumen (2mm ID × 250mm length).
The following claims have been validated for this device:
• One (1) Year sterile shelf life/maintenance of sterility claim:
• Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units.
• Compatibility with Table Top Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.
The SteriTite® container system is recommended to be used for sterilization of medical devices. Please see tables 1 and 2 below for the recommended total weight of SteriTite® containers with contents in steam sterilization:
Table 1: Recommended Load for SteriTite® Containers in Steam Sterilization:
Part Number Description Total weight load including container
SC02M Mini Size 2”H – Solid Bottom 6 lbs. ( 2.7 kg )
SC02MG Mini Size 2”H – Perforated Bottom 6 lbs. ( 2.7 kg )
SC03M Mini Size 3”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC03MG Mini Size 3”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC04M Mini Size 4”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC04MG Mini Size 4”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC02N ¾ Mini Size 2”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC02NG ¾ Mini Size 2”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC03N ¾ Mini Size 3”H – Solid Bottom 10 lbs. ( 4.5 kg )
SC03NG ¾ Mini Size 3”H – Perforated Bottom 10 lbs. ( 4.5 kg )
SC04H ½ Size 4”H – Solid Bottom 12 lbs. ( 5.4 kg )
SC04HG ½ Size 4”H – Perforated Bottom 12 lbs. ( 5.4 kg )
SC05H Half Size 5”H – Solid Bottom 12 lbs. ( 5.4 kg )
SC05HG Half Size 5”H – Perforated Bottom 12 lbs. ( 5.4 kg )
SC06H ½ Size 6”H – Solid Bottom 14 lbs. ( 6.4 kg )
SC06HG ½ Size 6”H – Perforated Bottom 14 lbs. ( 6.4 kg )
SC08H ½ Size 8”H – Solid Bottom 16 lbs. ( 7.3 kg )
SC08HG ½ Size 8”H – Perforated Bottom 16 lbs. ( 7.3 kg )
SC04Q ¾ Size 4”H – Solid Bottom 18 lbs. ( 8.2 kg )
SC04QG ¾ Size 4”H – Perforated Bottom 18 lbs. ( 8.2 kg )
SC05Q ¾ Size 5”H – Solid Bottom 22 lbs. ( 10.0 kg )
SC05QG ¾ Size 5”H – Perforated Bottom 22 lbs. ( 10.0 kg )
SC06Q ¾ Size 6”H – Solid Bottom 22 lbs. ( 10.0 kg )
SC06QG ¾ Size 6”H – Perforated Bottom 22 lbs. ( 10.0 kg )
SC08Q ¾ Size 8”H – Solid Bottom 25 lbs. ( 11.3 kg )
SC08QG ¾ Size 8”H – Perforated Bottom 25 lbs. ( 11.3 kg )
SC04F Full Size 4”H – Solid Bottom 25 lbs. ( 11.3 kg )
SC04FG Full Size 4”H – Perforated Bottom 25 lbs. ( 11.3 kg )
SC05F Full Size 5”H – Solid Bottom 25 lbs. ( 11.3 kg )
SC05FG Full Size 5”H – Perforated Bottom 25 lbs. ( 11.3 kg )
SC06F Full Size 6”H – Solid Bottom 25 lbs. ( 11.3 kg )
SC06FG Full Size 6”H – Perforated Bottom 25 lbs. ( 11.3 kg )
SC08F Full Size 8”H – Solid Bottom 25 lbs. ( 11.3 kg )
SC08FG Full Size 8”H – Perforated Bottom 25 lbs. ( 11.3 kg )
SC04L Long Size 4"H – Solid Bottom 30 lbs. ( 13.6 kg )
SC04LG Long Size 4"H – Perforated Bottom 30 lbs. ( 13.6 kg )
SC06L Long Size 6"H – Solid Bottom 30 lbs. ( 13.6 kg )
SC06LG Long Size 6"H – Perforated Bottom 30 lbs. ( 13.6 kg )
SC08L Long Size 8"H – Solid Bottom 30 lbs. ( 13.6 kg )
SC08LG Long Size 8"H – Perforated Bottom 30 lbs. ( 13.6 kg )
Table 2. Recommended Load and Sizing for SteriTite® Containers for Table Top Sterilizers
Part Number Description Total weight load including container
SC02M Mini Size 2”H – Solid Bottom 6 lbs. ( 2.7 kg )
SC02MG Mini Size 2”H – Perforated Bottom 6 lbs. ( 2.7 kg )
SC03M Mini Size 3”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC03MG Mini Size 3”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC04M Mini Size 4”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC04MG Mini Size 4”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC02N ¾ Mini Size 2”H – Solid Bottom 8 lbs. ( 3.6 kg )
SC02NG ¾ Mini Size 2”H – Perforated Bottom 8 lbs. ( 3.6 kg )
SC03N ¾ Mini Size 3”H – Solid Bottom 10 lbs. ( 4.5 kg )
SC03NG ¾ Mini Size 3”H – Perforated Bottom 10 lbs. ( 4.5 kg )
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173259: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173259
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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