510(k) · Cleared
ClearedBahadir Sterilization Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bahadir USA, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 22, 2024 as substantially equivalent to K131407 (Bahadir USA Corp., 2014) and 1 other predicate after a 136-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Mar 22, 2024
- Review
- 136 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K991023 (2000). 24 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 7 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 6 generations backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- 5 generations backK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- 4 generations backK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- 3 generations backK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- 2 generations backK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- 1 generation backK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
- This deviceK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −7 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −6 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| −5 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| −4 | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| −3 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| −2 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| −1 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
| 0 (this device) | K233578 | Bahadir Sterilization Containers | Bahadir USA, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131407 | Bahadir Sterilization TraysSummary page 12…CODE: KCT REGULATION: 21 CFR880.6850 REVIEW PANEL: GENERAL HOSPITAL ESTABLISHMENT REGESTRATION NUMBER: 3005741909 PREDICATE DEVICE: K131407, Bahadir Sterilization Containers (Primary Predicate) K214041, AESCULAP Aicon Container (Secondary Predicate… | 2014 |
| * | K214041 | Aesculap AICON ContainerSummary page 12…SPITAL ESTABLISHMENT REGESTRATION NUMBER: 3005741909 PREDICATE DEVICE: K131407, Bahadir Sterilization Containers (Primary Predicate) K214041, AESCULAP Aicon Container (Secondary Predicate)… | 2022 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
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. 2024, 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?
Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterility during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below: *STERIS V-PRO maX/maX2…
Read the full statement (987 words)
Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterility during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below:
*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles
*STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles
*STERRAD 100NX - Duo, Express, Standard and Flex Cycles
*STERRAD NX - Standard and Advanced Cycles
Bahadir Sterilization Containers Lumen Configurations
Sterilization Cycle Container Size Compatible Lumens
Full Size ≥0.77mm x ≤527mm (single, dual or triple channel)
≥0.8mm x ≤542mm (single, dual or triple channel)
≥0.48mm x ≤100mm (single, dual or triple channel) ≥1.3mm x ≤73mm (dead end lumen)
≥3mm x ≤298mm (rigid non-metallic lumen)
≥4mm x ≤424mm (rigid non-metallic lumen)
STERIS VPRO maX/maX2 Lumen Cycle Three-Quarter Size ≥0.77mm x ≤527mm (single, dual or triple channel)
≥0.8mm x ≤542mm (single, dual or triple channel)
≥0.48mm x ≤100mm (single, dual or triple channel)
≥1.3mm x ≤73mm (dead end lumen)
≥3mm x ≤298mm (rigid non-metallic lumen)
≥4mm x ≤424mm (rigid non-metallic lumen)
Half Size ≥0.77mm x ≤527mm (single, dual or triple channel)
≥0.8mm x ≤542mm (single, dual or triple channel)
≥0.48mm x ≤100mm (single, dual or triple channel)
≥1.3mm x ≤73mm (dead end lumen)
≥3mm x ≤298mm (rigid non-metallic lumen)
≥4mm x ≤424mm (rigid non-metallic lumen)
Full Size (2) flexible endoscopes with light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain Single or Dual channel lumens ≥1mm x ≤1050mm Or (1) flexible endoscope with light cord (if not integral to endoscope), endoscope accessories, mat and additional instruments. The flexible endoscope may contain Single or dual channel lumens that are ≥1mm x ≤1050mm. Additional single, dual or triple channel stainless steel lumen device that is ≥0.48mm x ≤100mm OR non-lumen device.
STERIS VPRO maX/maX2 Flexible Cycle Three-Quarter Size (2) flexible endoscopes with light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain Single or Dual channel lumens ≥1mm x ≤1050mm Or (1) flexible endoscope with light cord (if not integral to endoscope), endoscope accessories, mat and additional instruments. The flexible endoscope may contain Single or dual channel lumens that are ≥1mm x ≤1050mm. Additional single, dual or triple channel stainless steel lumen device that is ≥0.48mm x ≤100mm OR non-lumen device
Half Size (2) flexible endoscopes with light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain Single or Dual channel lumens ≥1mm x ≤1050mm Or (1) flexible endoscope with light cord (if not integral to endoscope), endoscope accessories, mat and additional instruments. The flexible endoscope may contain Single or dual channel lumens that are ≥1mm x ≤1050mm. Additional single, dual or triple channel stainless steel lumen device that is ≥0.48mm x ≤100mm OR non-lumen device
STERIS VPRO maX/maX2 Non-Lumen Cycle Full Size -Non lumened instruments Three-Quarter Size -Non lumened instruments Half Size -Non lumened instruments
Full Size ≥0.77mm x ≤410mm (single or dual channel) ≥1.8mm x ≤542mm (single or dual channel) ≥1.2mm x ≤275mm (triple channel) ≥1.8mm x ≤310mm (triple channel) ≥2.8mm x ≤317mm (triple channel)
STERIS VPRO s2/60 Lumen cycle Three-Quarter Size ≥0.77mm x ≤410mm (single or dual channel) ≥1.8mm x ≤542mm (single or dual channel) ≥1.2mm x ≤275mm (triple channel) ≥1.8mm x ≤310mm (triple channel) ≥2.8mm x ≤317mm (triple channel)
Half Size ≥0.77mm x ≤410mm (single or dual channel) ≥1.8mm x ≤542mm (single or dual channel) ≥1.2mm x ≤275mm (triple channel) ≥1.8mm x ≤310mm (triple channel) ≥2.8mm x ≤317mm (triple channel)
Full Size -Non-lumened instruments and instruments with diffusion restricted spaces (such as the hinged portion of forceps and scissors) -(1) surgical flexible endoscope or bronchoscope with light cord (if not integral to the endoscope). The flexible endoscope may be single or dual lumen device with lumens that are ≥1mm x ≤990mm
STERIS VPRO s2/60 Flexible Cycle Three-Quarter Size -Non-lumened instruments and instruments with diffusion restricted spaces (such as the hinged portion of forceps and scissors) -(1) surgical flexible endoscope or bronchoscope with light cord (if not integral to the endoscope). The flexible endoscope may be single or dual lumen device with lumens that are ≥1mm x ≤990mm
Half Size -Non-lumened instruments and instruments with diffusion restricted spaces (such as the hinged portion of forceps and scissors) -(1) surgical flexible endoscope or bronchoscope with light cord (if not integral to the endoscope). The flexible endoscope may be single or dual lumen device with lumens that are ≥1mm x ≤990mm
STERIS VPRO s2/60 Non-Lumen Cycle Full Size -Non lumened instruments Three-Quarter Size -Non lumened instruments Half Size -Non lumened instruments
Full Size (5) SS lumens 1mm I.D. x 150mm L (5) SS lumens 2mm I.D. x 400mm L
STERRAD NX Standard Cycle Three-Quarter Size (10) SS lumens 1mm I.D. x 150mm L
Half Size (10) SS lumens 1mm I.D. x 150mm L
Full Size (10) SS lumens 2mm I.D. x 500mm L
STERRAD NX Advanced Cycle Three-Quarter Size (6) SS lumens 1mm I.D. x 350mm L
Half Size (10) SS lumens 1mm I.D. x 200mm L
STERRAD 100NX Standard Cycle Full Size (5) SS lumens 1mm I.D. x 500mm L
Three-Quarter Size (5) SS lumens 1mm I.D. x 350mm L
Half Size (5) SS lumens 0.7mm I.D. x 200mm L
STERRAD 100NX Express Cycle Full Size Non lumened SS instruments
Three-Quarter Size Non lumened SS instruments
Half Size Non lumened SS instruments
Full Size (1)PTFE tubing 1.5 mm I.D. x 850mm L
STERRAD 100NX Duo Cycle Three-Quarter Size (1)PTFE tubing 1.5 mm I.D. x 850mm L
Half Size (1)PTFE tubing 1.5 mm I.D. x 850mm L
Full Size (1) Scope lumen 1mm I.D. x 850mm L
STERRAD 100 NX Flexible Cycle Three-Quarter Size (1) Scope lumen 1mm I.D. x 850mm L
Half Size (1)PTFE tubing 1mm I.D. x 850mm L
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233578: Bahadir Sterilization Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233578
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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