510(k) · Cleared
Recalled · Class II · 2023KARL STORZ Metal Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 6, 2021 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) after a 250-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 6, 2021
- Review
- 250 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844002 (1984). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK203198 KARL STORZ Metal Sterilization TraysKarl Storz Endoscopy America, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK231291 Perforated BasketsRichard Wolf Medical Instruments Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K231291Perforated BasketsRichard Wolf Medical Instruments Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K203198 | KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 5…erilization wrap/container Predicate devices: Symmetry Medical Polyvac Surgical Instrument Delivery System K012105 Description: The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encas… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231291 | Perforated Baskets | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2023 | Class II | Z-1991-2023 | No Marketing Application | 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 includes information regarding the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 13.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K231291 (Richard Wolf Medical Instruments Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K012105.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 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 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…
Read the full statement (217 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203198: KARL STORZ Metal Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203198
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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