510(k) · Cleared
ClearedRobinson Medsurg Quickscrew Rack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Robinson Medsurg, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 16, 2010 as substantially equivalent to K073551 (Smith & Nephew Inc., Endoscopy Div., 2008) and 2 other predicates after a 188-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Jun 16, 2010
- Review
- 188 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K844002 (1984). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 1 generation backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- This deviceK093800 Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −1 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K093800 | Robinson Medsurg Quickscrew Rack | Robinson Medsurg, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K073551 | Smith & Nephew Instrument TraysSummary page 1…and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith and Nephew Instrument Tray cleared under K073 55 1, Smith and Nephew Instrument Trays cleared under K090562, and the ContainMed Versipod Instrument Trays cleared under K071… | 2008 |
| * | K090562 | Smith & Nephew Instrument TraysSummary page 1…lly marketed device in commercial distribution: Smith and Nephew Instrument Tray cleared under K073 55 1, Smith and Nephew Instrument Trays cleared under K090562, and the ContainMed Versipod Instrument Trays cleared under K071783. E. Description of Device DEV… | 2009 |
| * | K071783 | Versapod (TM) Instrument TraysSummary page 1…trument Tray cleared under K073 55 1, Smith and Nephew Instrument Trays cleared under K090562, and the ContainMed Versipod Instrument Trays cleared under K071783. E. Description of Device DEVICE DESCRIPTION: The Robinson MedSurg QuickScrew Rack RCK24-143 is an instru… | 2008 |
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 26 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K073551.
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. 2010, 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 Robinson MedSurg QuickScrew Rack RCK24-143 is intended to organize, hold, and protect the QuickScrew screwdrivers for transport, storage, sterilization, and use during surgery. The subject instrument racks are suitable for use in prevacuum steam. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method: Prevacuum Steam Autoclave
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Drying Time: 60 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093800: Robinson Medsurg Quickscrew Rack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093800
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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