510(k) · Cleared
ClearedInstruSafe (R) Sterilization Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 16, 2018 as substantially equivalent to K123234 (Ermis Medizintechnik, 2013) after a 261-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Nov 16, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991023 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 5 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 4 generations backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- 3 generations backK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- 2 generations backK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- 1 generation backK123234 Ermis Sterilization Container SystemErmis Medizintechnik · 2013
- This deviceK180528 InstruSafe (R) Sterilization ContainerSummit Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −5 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −4 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| −3 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| −2 | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| −1 | K123234 | Ermis Sterilization Container System | Ermis Medizintechnik | 2013 | — |
| 0 (this device) | K180528 | InstruSafe (R) Sterilization Container | Summit Medical, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K123234 | Ermis Sterilization Container SystemSummary page 6…on Container Summit Medical, Inc. Page 2 of 7 Predicate Device Trade/Device Name/510(k) Ermis Medizintechnik Sterilization Container System - K123234 Reference Device Trade/Device Name/510(k) Aesculap SterilContainer System – K112671 (reference) Comparison of Subject… | 2013 |
| † | K112671 | Sterilcontainer System | 2012 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks. The InstruSafe® Sterilization…
Read the full statement (220 words)
The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.
The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filters.
The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
1320C (270 oF)
Drying Time Minimum: 30 minutes
Model Number | Description Total Container Loaded | Load Description
Maximum Weight (Ibs)
CS-3XXX Full 1/1 Perforated Container Lid Not applicable Metal (Stainless Steel)
CS-3XXX Full 1/1 Container Bottom 25 Ibs surgical instruments
CS-2XXX Three quarter % Perforated Container Lid | Not applicable like forceps, scissors,
CS-2XXX Three quarter % Container Bottom 25 Ibs clamps, etc. including
CS-1XXX One half % Perforated Container Lid Not applicable lumened /cannulated
CS-1XXX One half ¥ Container Bottom 18 Ibs Instruments.
CS-5XXX XL Perforated Container Lid Not applicable
CS-5XXX XL Container Bottom 25 lbs
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/K180528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180528: InstruSafe (R) Sterilization Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180528
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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