# K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Medical, Inc.
- Decided: Dec 28, 2015 after 83 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: 5 generations back to K844002 (1984). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141616: Sterilization Cassette, Oticon Medical AB (2014) Summary page 5.

## Most influential descendants
- K190667: Sonopet iQ Sterilization Tray (2019), 0 descendants of its own

## Indications for use
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are designed. The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles: No Method Cycle 1 Ethylene Oxide (EtO) Preconditioning Parameters Temperature (°C) 55°C (131°F) Chamber Humidity 70% RH Vacuum Set Points 1.3 psia Time 30 minutes Exposure Concentration 725 mg/L, 100% EO Temperature (°C) 55°C +2°C (131°F +5°F) Time 1 hour Chamber Humidity (%) 70% RH (50-80%) +5% Aeration Aeration Time 12 hours Temperature 35°C - 54°C (95°F – 129°F) 2 Prevacuum Steam Cycle 1 Cycle 2 Wrapping Double Double Temperature 132°C (270°F) 134°C (273°F) Sterilization Time 4 minutes 3 minutes Dry Time 30 minutes 30 minutes 3 Gravity Steam Cycle 1 Cycle 2 Wrapping Double Double Temperature 132°C (270°F) 134°C (273°F) Sterilization Time 15 minutes 10 minutes Dry Time 30 minutes 30 minutes 4 STERIS® V-PRO® 1 Standard 5 STERIS® V-PRO® 1 Plus Non-Lumen or Lumen 6 STERIS® V-PRO® maX Non-Lumen or Lumen 7 STERRAD® 100S Standard 8 STERRAD® NX® Standard 9 STERRAD® 100NX® Standard In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY. Method Cycle Immediate Use Steam Sterilization (“Flash”) Cycle 1 Cycle 2 Wrapping None None Prevacuum Steam Temperature 132°C (270°F) 134°C (273°F) Sterilization Time 4 minutes 3 minutes Dry Time None None The maximum product loads for the trays are as follows: Tray Description | Catalog Number | Maximum Tray Product Load | Total Loaded Tray Weight Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1), Scope (Qty. 2), Adapter (Qty. 2) | 10.58 lbs Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1), Scope (Qty. 2), Adapter (Qty. 2) | 10.58 lbs Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1) | 8.83 lbs * Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).

Source page: https://510kreport.com/device/K152951
Methodology: https://510kreport.com/methodology