510(k) · Cleared
ClearedBahadir 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 Aug 12, 2014 as substantially equivalent to K112090 (Bahadir USA Corp., 2012) and 3 other predicates after a 454-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Aug 12, 2014
- Review
- 454 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K991023 (2000). 15 ancestors in all, the oldest K792558 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 6 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 5 generations backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- 4 generations backK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- 3 generations backK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- 2 generations backK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- 1 generation backK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- This deviceK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
- Descendant · cites it directly · 0 of its ownK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K233578Bahadir Sterilization ContainersBahadir USA, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −6 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −5 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| −4 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| −3 | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| −2 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| −1 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| 0 (this device) | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
| +1 | K233578 | Bahadir Sterilization Containers | Bahadir USA, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K112090 | Bahadir Sterilization TraysSummary page 6…fication Name Sterilization Wraps, Trays, Containers Class II – KCT Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Predicate Devices Bahadir – K112090 Bahadir– K102146 Aesculap – K053389 Sklar – K091720 K131407 Intended Use:… | 2012 |
| * | K102146 | Bahadir Sterilization TraysSummary page 6…rilization Wraps, Trays, Containers Class II – KCT Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Predicate Devices Bahadir – K112090 Bahadir– K102146 Aesculap – K053389 Sklar – K091720 K131407 Intended Use: Intended for use… | 2010 |
| * | K053389 | Aesculap Sterilcontainer SystemSummary page 6…rays, Containers Class II – KCT Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Predicate Devices Bahadir – K112090 Bahadir– K102146 Aesculap – K053389 Sklar – K091720 K131407 Intended Use: Intended for use in hospitals and h… | 2006 |
| * | K091720 | Sklarlite Rigid Sterilization Container SystemSummary page 6…Class II – KCT Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Predicate Devices Bahadir – K112090 Bahadir– K102146 Aesculap – K053389 Sklar – K091720 K131407 Intended Use: Intended for use in hospitals and healthcare facili… | 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 |
|---|---|---|---|
| K233578 | Bahadir Sterilization Containers | 2024 | 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 14 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K233578 (Bahadir USA, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2014, 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 for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during…
Read the full statement (522 words)
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised.
Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18” maximum configuration. Containers are marked as to their height to facilitate this process.
3 containers MAXIMUM can be stacked.
Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process.
The devices included in this submission are to be used with a pre-vacuum, three pulse standard cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
Flat Size Y310.05A Mini Size Y410.04A Dental Size Y510.04A
Flat Size Y310.08A Mini Size Y410.07A Dental Size Y510.06A
Flat Size Y311.08A Mini Size Y410.10A Dental Size Y510.08A
Mini Size Y411.04A Dental Size Y510.10A
Mini Size Y411.07A Dental Size Y510.13A
Mini Size Y411.10A Dental Size Y511.04A
Dental Size Y511.06A
Dental Size Y511.08A
Dental Size Y511.10A
Dental Size Y511.13A
Full size Y110.10W ¾ size Y210.10W ½ size Y310.10W
Full size Y111.10W ¾ size Y210.13W ½ size Y310.13W
Full size Y110.13W ¾ size Y210.15W ½ size Y310.15W
Full size Y111.13W ¾ size Y211.10W ½ size Y310.20W
Full size Y110.15W ¾ size Y211.13W ½ size Y310.26W
Full size Y111.15W ¾ size Y211.15W ½ size Y311.10W
Full size Y110.20W ½ size Y311.13W
Full size Y111.20W ½ size Y311.15W
Full size Y111.26W ½ size Y311.20W
Wide size Y110.62W ½ size Y311.26W
Wide size Y110.68W
Wide size Y111.62W
Wide size Y111.68W
The Containers have been validated for sterilization of instrument load weights shown below, and may include in this max load weight up to 2 instruments with lumens no smaller than 1 mm in diameter and no longer than 300 mm in length for the Full Size, ¾ Size, and Wide Body Containers, and no smaller than 1 mm in diameter and no longer than 200mm in length for the Half Size, Mini, Flat, & Dental Containers.
The maximum load weights for the Sterilization Containers which are the subject of this premarket notification are as follows:
Maximum Recommended Load (including basket and contents)
LBS.
Model Dimensions (mm)
580X280X100 24.75
580X280X135 24.75
1/1 Size
580X280X150 24.75
Container
580X280X200 24.75
580X280X260 24.75
465x280x100 12.5
3/4 Size
465x280x135 12.5
Container
465x280x150 12.5
285x280x100 9.25
1/2 Size 285x280x135 9.25
285x280x150 9.25
Container 285x280x200 9.25
285x280x260 9.25
600x400x120 24.75
Wide Body
Container 600x400x180 24.75
285x280x55 9.25
Flat
Container 285x280x85 9.25
300x140x40 6.0
Mini
300x140x70 6.0
Container 300x140x100 6.0
310x190x40 9.25
Dental
310x190x65 9.25
Container 310x190x130 9.25
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131407: Bahadir Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131407
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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