510(k) · Cleared
ClearedInstruSafe Instrument Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summitt Medical, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 30, 2021 as substantially equivalent to K150540 (Summit Medical, Inc., 2015) after a 253-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Nov 30, 2021
- Review
- 253 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K133015 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K150540 | Instru-Safe Instrument Protection SystemSummary page 5…assettes and other accessories Name: Regulatory Class II Class: Product Code: KCT Predicate Device Details Predicate Device: K150540 – Instru-Safe Instrument Protection System – SUMMIT MEDICAL, INC. 21 CFR 880.6850 - KCT Device Descript… | 2015 |
| † | K190260 | STERIZONE (R) VP4 Sterilizer | 2019 |
| † | K133015 | Instru-Safe Instrument Protection System | 2014 |
| † | K141163 | Sterizone Sterilizer | 2014 |
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 7 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
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?
InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterilization Cycle 1. The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap…
Read the full statement (228 words)
InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterilization Cycle 1. The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to maintain sterility.
Summit Medical has validated the use of the InstruSafe Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples of medical devices including general instruments, rigid and semi-rigid instruments with lumens, and flexible endoscopes. The validation provided information that has been used to establish design limits that are applied across the range of InstruSafe Instrument Protection System cassettes to ensure that all models fall within the validated limits for cassette ventilation, internal shelving, and weight:
• Minimum ventilation-to-volume ratio, general instruments: 0.073
• Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
• Maximum number of internal shelves: Two (2)
• Maximum cassette weight (including contents): 25 lbs/cassette
Refer to Table for the validated loads using InstruSafe Instrument Protection System cassettes. Refer to the sterilizer manufacturer’s instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210836: InstruSafe Instrument Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210836
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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