# K233578: Bahadir Sterilization Containers

- Pathway: 510(k) (Traditional)
- Applicant: Bahadir USA, LLC
- Decided: Mar 22, 2024 after 136 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K991023 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131407: Bahadir Sterilization Trays, Bahadir USA Corp. (2014) Summary page 12.
- K214041: Aesculap AICON Container, Aesculap, Inc. (2022) Summary page 12.

## Indications for use
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

Source page: https://510kreport.com/device/K233578
Methodology: https://510kreport.com/methodology