510(k) · Cleared
ClearedInstru-Safe Instrument Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 13, 2014 after a 169-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Mar 13, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK133015 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK171520 SteriZign Signatur Device Protection SystemSterizign Precision Technologies, LLC · 2018
- Descendant · cites it directly · 1 of its ownK150540 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK253187 SteriBest® Sterilization Tray SystemMastel Surgical · 2026
- Descendant · 2 generations on · 0 of its ownK210836 InstruSafe Instrument Protection SystemSummitt Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK151166 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171520SteriZign Signatur Device Protection SystemSterizign Precision Technologies, LLC · 2018 · cites it directly1descendant
- K150540Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2015 · cites it directly1descendant
- K253187SteriBest® Sterilization Tray SystemMastel Surgical · 2026 · 2 generations on0descendants
- K210836InstruSafe Instrument Protection SystemSummitt Medical, LLC · 2021 · 2 generations on0descendants
- K151166Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133015 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2014 | — |
| +1 | K171520 | SteriZign Signatur Device Protection System | Sterizign Precision Technologies, LLC | 2018 | — |
| +1 | K150540 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2015 | — |
| +2 | K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026 | — |
| +2 | K210836 | InstruSafe Instrument Protection System | Summitt Medical, LLC | 2021 | — |
| +1 | K151166 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K171520 (Sterizign Precision Technologies, LLC, 2018) has gone furthest, with 1 descendant 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. 2014, 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?
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during pre-vacuum steam sterilization cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid…
Read the full statement (95 words)
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during pre-vacuum steam sterilization cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.
Autoclave Sterilization Parameter
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133015: Instru-Safe Instrument Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133015
Report an extraction error
Are you the manufacturer?
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