510(k) · Cleared
ClearedAdvanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 28, 2015 as substantially equivalent to K141616 (Oticon Medical AB, 2014) after an 83-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- Dec 28, 2015
- Review
- 83 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. 1 later device descends 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 backK141616 Sterilization CassetteOticon Medical AB · 2014
- This deviceK152951 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and…Paragon Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK190667 Sonopet iQ Sterilization TrayParagon Medical · 2019
Most influential descendants
Showing 1 of 1 · See all- K190667Sonopet iQ Sterilization TrayParagon Medical · 2019 · cites it directly0descendants
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 | K141616 | Sterilization Cassette | Oticon Medical AB | 2014 | — |
| 0 (this device) | K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera… | Paragon Medical, Inc. | 2015 | — |
| +1 | K190667 | Sonopet iQ Sterilization Tray | Paragon Medical | 2019 | — |
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 |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K141616 | Sterilization CassetteSummary page 5…ners, trays, cassettes and other accessories, Class II Product Code KCT Predicate Device Sterilization cassette by Oticon Medical AB, k141616 Device Description: The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera… | 2014 |
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 |
|---|---|---|---|
| K190667 | Sonopet iQ Sterilization Tray | 2019 | 0 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K190667 (Paragon Medical, 2019) has gone furthest, with 0 descendants of its own.
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. 2015, 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 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are designed. The trays are not intended to maintain sterility; they are intended to be used in conjunction with…
Read the full statement (449 words)
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are designed. The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:
No Method Cycle
1 Ethylene Oxide (EtO) Preconditioning Parameters
Temperature (°C) 55°C (131°F)
Chamber Humidity 70% RH
Vacuum Set Points 1.3 psia
Time 30 minutes
Exposure
Concentration 725 mg/L, 100% EO
Temperature (°C) 55°C +2°C (131°F +5°F)
Time 1 hour
Chamber Humidity (%) 70% RH (50-80%) +5%
Aeration
Aeration Time 12 hours
Temperature 35°C - 54°C (95°F – 129°F)
2 Prevacuum Steam Cycle 1 Cycle 2
Wrapping Double Double
Temperature 132°C (270°F) 134°C (273°F)
Sterilization Time 4 minutes 3 minutes
Dry Time 30 minutes 30 minutes
3 Gravity Steam Cycle 1 Cycle 2
Wrapping Double Double
Temperature 132°C (270°F) 134°C (273°F)
Sterilization Time 15 minutes 10 minutes
Dry Time 30 minutes 30 minutes
4 STERIS® V-PRO® 1 Standard
5 STERIS® V-PRO® 1 Plus Non-Lumen or Lumen
6 STERIS® V-PRO® maX Non-Lumen or Lumen
7 STERRAD® 100S Standard
8 STERRAD® NX® Standard
9 STERRAD® 100NX® Standard
In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.
Method Cycle
Immediate Use Steam Sterilization (“Flash”) Cycle 1 Cycle 2
Wrapping None None
Prevacuum Steam
Temperature 132°C (270°F) 134°C (273°F)
Sterilization Time 4 minutes 3 minutes
Dry Time None None
The maximum product loads for the trays are as follows:
Tray Description | Catalog Number | Maximum Tray Product Load | Total Loaded Tray Weight
Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1), Scope (Qty. 2), Adapter (Qty. 2) | 10.58 lbs
Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1), Scope (Qty. 2), Adapter (Qty. 2) | 10.58 lbs
Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1), Light Cable (Qty. 1), Coupler (Qty. 1) | 8.83 lbs
* Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152951
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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