510(k) · Cleared

Cleared

Perforated Baskets

K231291510(k) TraditionalCleared Jun 3, 2024396-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Jun 3, 2024 as substantially equivalent to K203198 (Karl Storz Endoscopy America, Inc., 2021) after a 396-day review. Its family tree reaches back 5 generations to 1984.

Decided: Jun 3, 2024
Review: 396 days
Class: Class II
Product code: KCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K844002 (1984). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
1 generation backK203198 KARL STORZ Metal Sterilization TraysKarl Storz Endoscopy America, Inc. · 2021 · Recalled
This deviceK231291 Perforated BasketsRichard Wolf Medical Instruments Corporation · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K844002	HU-Friedy Ims Cassette System	Hu-Friedy Mfg. Co., Inc.	1984	—
−4	K980065	C/T Med-Systems Cassette System	C/T Med System, Ltd.	1998	—
−3	K990761	Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette	Tuttnauer U.S.A Co, Ltd.	1999	—
−2	K012105	Polyvac Surgical Instrument Delivery System	Symmetry Medical, Inc.	2002	—
−1	K203198	KARL STORZ Metal Sterilization Trays	Karl Storz Endoscopy America, Inc.	2021	1
0 (this device)	K231291	Perforated Baskets	Richard Wolf Medical Instruments Corporation	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0

FIG. 1 — Lineage of K231291, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KCT device

#1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K203198	KARL STORZ Metal Sterilization Trays Summary page 7 …1 K231291 510(k) Summary 2. Predicate Device Name of Predicate Device: KARL STORZ Metal Sterilization Trays 510(k) Number: K203198 Regulatory Class: II Product Code: KCT Manufacturer: Karl Storz Endoscopy America Inc 3. Device Descrip…	Karl Storz Endoscopy America, Inc.	2021	1

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 40 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
1 of the 7 ancestors has a recall of any class.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · KCT

11in 2025

2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007high 236 (2012) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KCT

17in 2022

2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCT

50in 2025

2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	199	0	2
2008	6	182	0	8
2009	6	89	0	5
2010	12	202	1	3
2011	6	117	2	3
2012	10	236	0	2
2013	8	131	1	6
2014	11	169	1	5
2015	15	151	0	6
2016	12	182	3	16
2017	10	211	1	3
2018	15	192	0	22
2019	18	187	0	15
2020	14	134	0	66
2021	18	185	1	26
2022	11	137	17	8
2023	10	94	0	30
2024	8	106	0	18
2025	11	205	0	50
2026	9	122	0	—

What is it indicated for?

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…

Read the full statement (321 words)

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)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231291 · printed Nov 5, 2026

Cite this page

510(k) Report. “K231291: Perforated Baskets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231291

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026