# K231291: Perforated Baskets

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Jun 3, 2024 after 396 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.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203198: KARL STORZ Metal Sterilization Trays, Karl Storz Endoscopy America, Inc. (2021) Summary page 7.

## Indications for use
The products are used to store medical devices before, during, and after sterilization. The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market. The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 °C Drying time: 20 min The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs). All measurements are in millimeter and are coded as follows [WidthxHeightxLength]. UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET – KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET – KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)

Source page: https://510kreport.com/device/K231291
Methodology: https://510kreport.com/methodology