510(k) · Cleared
ClearedPivot System Sterilization case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rp Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 25, 2019 as substantially equivalent to K173615 (Paragon Medical, 2018) after a 502-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Nov 25, 2019
- Review
- 502 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163279 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2017
- 1 generation backK173615 Stryker Universal Select Sterilization Tray SystemParagon Medical · 2018
- This deviceK181845 Pivot System Sterilization caseRp Medical, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 4 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 3 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 2 generations backK163279 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2017
- 1 generation backK173615 Stryker Universal Select Sterilization Tray SystemParagon Medical · 2018
- This deviceK181845 Pivot System Sterilization caseRp Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −4 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −3 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −2 | K163279 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −1 | K173615 | Stryker Universal Select Sterilization Tray System | Paragon Medical | 2018 | — |
| 0 (this device) | K181845 | Pivot System Sterilization case | Rp Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 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.
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 35 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- None of the 15 ancestors has a recall.
- 1 other device also cites its predicate K173615.
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. 2019, 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 RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following…
Read the full statement (309 words)
The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles:
Enclosure Pivot System Sterilization Case
Cycle Pre-Vacuum
Temperature 132°C (270°F)
Sterilization Time 4 minutes
Pressure 2-15 PSIA
Minimum Dry Time 30 minutes in chamber
The maximum validated product loads for the trays in containers are as follows:
2-Level Rack, Level 2, Pivot System Sterilization Tray
39.1960.01, RP OST Tool Handle, 3 each
39.1960.02, RP OST Tool Rod, 3 each
39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each
39.1960.51.02 RP OST Tool 1D RH 22mm, 1 each
39.1960.20.01 RP OST Angle 162mm, 1 each
39.1960.20.02 RP OST Angle 19mm, 1 each
39.1960.20.03 RP OST Angle 21.5mm, 1 each
39.1960.40.01 RP TM Spike Blade, 1 each
39.1960.60.01 OST Reverse Blade 11mm, 1 each
39.1960.60.02 OST Reverse Blade 16mm, 1 each
39.1960.30.01 RP OST Tool Curve 16mm, 1 each
39.1960.30.02 RP OST Tool Curve 19mm, 1 each
39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each
39.1960.10.01 RP OST Straight 20mm, 1 each
39.1960.10.02 RP OST Straight 40mm, 1 each
39.1960.10.03 RP OST Straight 43mm, 1 each
39.1960.10.04 RP OST Straight 47.5mm, 1 each
39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each
39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each
2-Level Rack — Level 1, Pivot System Sterilization Tray
39.1960.01, RP OST Tool Handle, 1 each
39.1960.02, RP OST Tool Rod, 1 each
39.1960.05, Retractor, 1 each
39.1960.07, RP OST System, 1 each
39.1960.70.01 RP Curved Hip Long, 1 each
39.1960.70.02 RP Curved Hip Short, 1 each
39.1960.70.03 RP Curved Hip, 1 each
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/K181845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181845: Pivot System Sterilization case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181845
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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