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 Jun 7, 2012 as substantially equivalent to K102146 (Bahadir USA Corp., 2010) after a 322-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 7, 2012
- Review
- 322 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991023 (2000). 12 ancestors in all, the oldest K871202 (1987). 2 later devices descend from it, 1 citing it directly.
- 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 backK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- This deviceK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012
- 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 2 of 2 · See allView 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 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| 0 (this device) | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | — |
| +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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102146 | Bahadir Sterilization TraysSummary page 1…2 Name of Device BAHADIR STERILIZATION TRAYs (INCLUDING WIDE BODY) Classification Name Sterilization Wraps, Trays, Containers Class 2 - KCT Predicate Device Bahadir - K102146 Description of the Device Intended Use Intended for use in hospitals and healthcare facilities to contain other… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131407 | Bahadir Sterilization Trays | 2014 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K131407 (Bahadir USA Corp., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102146.
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. 2012, 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 (190 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 Y1 11.10W %/SizeY211.1 OW %/Size Y31l1-1OW
Full Size Y1 11.13W %/SizeY2ll.13W 1/2Size Y311.13W
Full SizeY1lll.1 5W %Size Y211.15W 1/Size Y3ll.15W
Full Size Y1 11.20W %ASizeY3ll.20W
Full Size Y1 1.26W 'A Size Y31 1.26W
Full Size Y1 1O.62W
Full Size Y1 10.68W
Full Size Y1 11.62W
Full Size Y1 11.68W
(Full Size Max Load Wt. 24.75 lbs (% Max Load Wt. 12.5 lbs ('A Size Max Load Wt. 9.25 lbs
including basket & instruments) including basket & instruments) including basket & instruments)
Lumen Size min 1mm diameter Lumen Size min 1mm diameter Lumen size min 1mm diameter
X 300mm length X 200mm length X 200mm length
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112090: 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/K112090
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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