# K203198: KARL STORZ Metal Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Jul 6, 2021 after 250 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K231291: Perforated Baskets (2024), 0 descendants of its own

## Recalls of this device
- Apr 6, 2023 · Class II · Z-1991-2023: Metal 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 also 

## Indications for use
The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132°C for four minutes with a 20 minute dry time). When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. The system has been validated with devices with working channels?: 0.2mm and a maximum length of 240mm. Tray Catalog Number Dimensions Intended Load & Maximum Weight (Karl Storz Instruments Only) 11580A 7"x5.31"x1.46" Sterilization of probes and dilators 1lb. l1580B 10.8"x6.9"x1.46" Telescope sterilization tray 2.4lbs. 11580C 13.5"x7"x1.38" Telescope sterilization tray 5lbs. 11580D 10.8"x6.9"x1.46" Telescope sterilization tray 2.75lbs. 39501Al 1l.4"x2.36"x2" Cleaning/sterilization basket: Rigid scope l.25lbs. 39501A2 13.9"x4.92"x2.13" Cleaning/sterilization basket: 2 rigid scopes and LT cable 3.75lbs. 39501B2 19"x4.9"x2.l" Cleaning/Sterilization basket; 2 rigid scopes/I LT cable 5lbs. 39501BEC 18.9"x4.9"x2.1" Cleaning/sterilization basket: Scope & LT cable 3lbs 39501C 26.3"x3.l"x2" Cleaning/sterilization basket for telescopes up to 670mm 2.5lbs 39501CEC 23.8"x4.9"x2.1" Cleaning/sterilization basket: Scope & LT cable 3lbs 39501F 22.4"x3.15x2.05" Cleaning/sterilization basket: Rigid endoscope 3.5lbs. 39501LC2 10.24"x4.72"x6.7" Cleaning/sterilization basket: Laryngoscope blades and module 3.2lbs 39501X 25.3"x5.9"x3.l" Cleaning/sterilization basket for telescopes up to 43cm 2.4lbs 39501XK 18.ll"x5.9"x3.15" Cleaning/sterilization basket: telescopes 2.4lbs 39501XP 18.ll"x5.9"x3.15" Cleaning/Sterilization basket for telescopes 2.4lbs 39550A 18.9"x9.84"x2.36" Cleaning/Sterilization basket: shaver and cable 3.25lbs.

Source page: https://510kreport.com/device/K203198
Methodology: https://510kreport.com/methodology