# K203572: Karl Storz Radel Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: May 7, 2021 after 151 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844002 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 4.

## Recalls of this device
- Apr 5, 2023 · Class II · Z-1981-2023: Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that als

## Indications for use
The KARL STORZ RADEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132°C 4 minutes). The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap. KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.25 mm and a length of 240 mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77 mm and a length of 420 mm. Tray Catalog Number Intended Load Maximum Weight (Karl Storz Instruments Only) 27717A Trocar/Cannula 5.0 lbs. 27717B Take-Apart Instruments 5.0 lbs. 39231XA Karl Storz General Instruments 5.0 lbs. 39301A Two Rigid Telescopes 2.71 lbs. 39301C Two Rigid Telescopes 3.21 lbs. 39301C1 One Rigid Telescope/One Light Cable 3.17 lbs. 39311A Four Telescopes/One Light Cable 6.86 lbs. 39317A Three Telescopes/One Light Cable 6.86 lbs.

Source page: https://510kreport.com/device/K203572
Methodology: https://510kreport.com/methodology