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 Dec 23, 2014 as substantially equivalent to K133015 (Summit Medical, Inc., 2014) after a 97-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Dec 23, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133015 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK133015 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2014
- This deviceK142630 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K133015 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2014 | — |
| 0 (this device) | K142630 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K133015 | Instru-Safe Instrument Protection SystemSummary page 9…tal Predicate Tradename: Instru-Safe Instrument Protection System Device: 510(k) Holder: Summit Medical Inc. 510(k) #: K133015 Device Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / Description: trays… | 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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K133015.
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 a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid…
Read the full statement (184 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 a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Lumen claims for Four (4) Minute Pre-Vacuum Steam Sterilization Cycle:
Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens
IN-2681 | 3mm | 200mm | 1
IN-2681 | 1mm | 65mm | 1
IN-0000 | 1mm | 400mm | 5
IN-0000 | 3mm | 400mm | 1
IN-0000 | 5mm | 400mm | 1
IN-6105 | 5mm | 241mm | 1
The worst case validated load by vent-to-volume calculation is the IN-2681 tray.
The total weight of the container system (e.g. container, tray and instrument load) must not exceed 25 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142630: 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/K142630
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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