510(k) · Cleared
Recalled · Class II · 2014Bahadir Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bahadir USA Corp. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 18, 2010 as substantially equivalent to K050570 (Miltex, Inc., 2005) and 2 other predicates after a 111-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K991023 (2000). 11 ancestors in all, the oldest K871202 (1987). 3 later devices descend from it, 2 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 deviceK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010
- Descendant · cites it directly · 2 of its ownK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
Most influential descendants
Showing 3 of 3 · See allView 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) | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | — |
| +1 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| +1 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
| +2 | K233578 | Bahadir Sterilization Containers | Bahadir USA, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1997 | 3 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 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? (3)
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 |
|---|---|---|---|
| * | K050570 | Miltex Rigid Sterilization Container SystemSummary page 1…Name of Device BAHADIR STERILzxIZTON TRAys Classification Name Sterilization Wraps, Trays, Containers Class 2 - KCT Predicate Device Miltex Rigid Sterilization Trays - K050570 Sklar - Sklarl-ite Rigid Sterilization Container - K091720… | 2005 |
| * | K072563 | Miltex Rigid Container SystemsSummary page 4…__ The containers are the same design, same materials, same shapes, and sizes. Feature Bahadir Miltex K072563 SkiarLite K091720 Intended Use Intended for use in Intended far use in Intended for use in… | 2008 |
| * | K091720 | Sklarlite Rigid Sterilization Container SystemSummary page 1…Name Sterilization Wraps, Trays, Containers Class 2 - KCT Predicate Device Miltex Rigid Sterilization Trays - K050570 Sklar - Sklarl-ite Rigid Sterilization Container - K091720 Wlb a1LI 16… | 2010 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Jul 30, 2014 | Class II | Z-2624-2014 | Employee error | Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K112090 (Bahadir USA Corp., 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K050570.
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. 2010, 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?
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container. The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes. The devices (natural aluminum color containers and…
Read the full statement (179 words)
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size 1/1 Y110.20
Full Size 1/1 Y110.15
Full Size 1/1 Y110.13
Full Size 1/1 Y110.10
¾ Size Y210.10
¾ Size Y210.15
¾ Size Y210.13
½ Size Y310.20
½ Size Y310.15
½ Size Y310.13
½ Size Y310.10
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for ½ size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.
The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102146: Bahadir Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102146
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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