510(k) · Cleared
ClearedErmis Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ermis Medizintechnik · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 5, 2013 as substantially equivalent to K091720 (Sklar Corp., 2010) after a 263-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jul 5, 2013
- Review
- 263 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K991023 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 4 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 3 generations backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- 2 generations backK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- 1 generation backK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- This deviceK123234 Ermis Sterilization Container SystemErmis Medizintechnik · 2013
- Descendant · cites it directly · 0 of its ownK180528 InstruSafe (R) Sterilization ContainerSummit Medical, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180528InstruSafe (R) Sterilization ContainerSummit Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −4 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −3 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| −2 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| −1 | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| 0 (this device) | K123234 | Ermis Sterilization Container System | Ermis Medizintechnik | 2013 | — |
| +1 | K180528 | InstruSafe (R) Sterilization Container | Summit Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K121909 | FDA’s K121909 is Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| * | K091720 | Sklarlite Rigid Sterilization Container SystemSummary page 2…r Sahadir Sterilization Trays K 12190 Bahadir USA Corn. SkiarLite Rigid Slerilizatioon Container K091 720 Sklar Instruments Systems 001 510K Sunriajvl 5,doc… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180528 | InstruSafe (R) Sterilization Container | 2018 | 0 |
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 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K180528 (Summit Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091720.
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. 2013, 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 ERMIS Sterilization Container System Is Intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, % Size, %1size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of…
Read the full statement (145 words)
The ERMIS Sterilization Container System Is Intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, % Size, %1size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters.
The containers are reusable devices designed to be used with the following sterilization cycle parameters:
Pre Vacuum cycle:
4 minutes 3 minutes
132 0 C (270-F) 135-C (273-F)
Drying Time minimum 20 minutes Drying Time minimum 16 minutes
Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles
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/K123234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123234: Ermis Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123234
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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