510(k) · Cleared
ClearedIntuitive Surgical Instrument and Accessories Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 28, 2008 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 2 other predicates after a 203-day review. Its family tree reaches back 5 generations to 1984. 7 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 203 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K844002 (1984). 9 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- 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 backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- This deviceK072211 Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK180127 TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK200632 TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK202268 CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020
- Descendant · 4 generations on · 1 of its ownK241927 Synthes Graphic Case & Tray SystemSynthes GmbH · 2025
- Descendant · 5 generations on · 0 of its ownK253791 PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect…DePuy Mitek, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019 · cites it directly6descendants
- K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020 · 2 generations on5descendants
- K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020 · 3 generations on3descendants
- K241927Synthes Graphic Case & Tray SystemSynthes GmbH · 2025 · 4 generations on1descendant
- K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc. · 2026 · 5 generations on0descendants
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 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| 0 (this device) | K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | Intuitive Surgical, Inc. | 2008 | — |
| +1 | K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | 2019 | — |
| +2 | K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | 2020 | — |
| +3 | K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | 2020 | — |
| +4 | K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025 | — |
| +5 | K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula… | DePuy Mitek, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 1…Device Class: Class 11 (KCT) Predicate PolyVac Surgical Instrument Delivery System (K012105) Devices PolyVac Inc. Paragon Medical Surgical Instrum… | 2002 |
| * | K032119 | Paragon Medical Surgical Instrument Delivery System VariousSummary page 1…PolyVac Inc. Paragon Medical Surgical Instrument Delivery System (K0321 19) Paragon Medical, Inc. Intuitive Surgical Instrument and Accessory Sterilization Trays 510… | 2003 |
| * | K033222 | Olympus Sterilization TraysSummary page 2…ion Trays 510OK Page 1 of 4 Predicate Olympus Sterilization Trays (K033222) Devices (Cont.) Olympus Winter & lbe Device Intuitive Surgical® Instrument a… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180127 | TCAT (R) THA Instrument Tray Set | 2019 | 6 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K180127 (THINK Surgical, Inc., 2019) has gone furthest, with 6 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. 2008, 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?
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table I below. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping…
Read the full statement (127 words)
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table I below.
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Autoclave Sterilization Parameter:
Cycle: Pre-vacuum
Temperature: 270-272 0 F (132-1 34 0 C)
Minimum Exposure Time: 4 mins
Minimum Dry Time: 30 mins
Table 2 provides the description of the 4 configurations of the Intuitive Surgical Instrument and Accessory Sterilization Trays
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072211: Intuitive Surgical Instrument and Accessories Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072211
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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