510(k) · Cleared
ClearedAygün Sterilization Container Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aygun Surgical Instruments Co., Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 12, 2023 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 12, 2023
- Review
- 75 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2023, 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 Aygiin Sterilization Container Systems is indicated for use by hospitals and health care facilities to: • Organize and protect stainless steel, aluminum, titanium, plastic, and silicone surgical instruments during the reprocessing process, • Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles, • Maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare…
Read the full statement (216 words)
The Aygiin Sterilization Container Systems is indicated for use by hospitals and health care facilities to:
• Organize and protect stainless steel, aluminum, titanium, plastic, and silicone surgical instruments during the reprocessing process,
• Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles,
• Maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container remains uncompromised,
• The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is designed for use with stainless steel, aluminum, titanium, plastic, and silicone surgical instruments.
For effective sterilization and drying of any size Aygiin Sterilization Container System, the recommended maximum combined weight of the single container, lid, basket/tray, and basket/tray contents is defined below. The qualified lumen size, representing the minimum diameter and maximum length, which has been qualified for use, is also shown below.
Type: Pre-vacuum Steam Sterilization.
Cycle: Temperature: 132°C, Exposure Time: 4 minutes, Drying Time: 30 minutes.
Stackable: No.
Instrument Type: stainless steel, aluminum, titanium, plastic, and silicone surgical instruments.
Lumen Size: ≥ Full Size: 1mm x 500mm, ≤ Three Quarter Size: 1mm x 200mm
Maximum Weight: ≥ Three Quarter Size: 25 lbs., ≤ Half Size 15 lbs.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K233222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233222: Aygün Sterilization Container Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026