510(k) · Cleared
ClearedSteriZign Signatur Device Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterizign Precision Technologies, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 7, 2018 as substantially equivalent to K133015 (Summit Medical, Inc., 2014) after a 259-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Feb 7, 2018
- Review
- 259 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133015 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK133015 Instru-Safe Instrument Protection SystemSummit Medical, Inc. · 2014
- This deviceK171520 SteriZign Signatur Device Protection SystemSterizign Precision Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK253187 SteriBest® Sterilization Tray SystemMastel Surgical · 2026
Most influential descendants
Showing 1 of 1 · See all- K253187SteriBest® Sterilization Tray SystemMastel Surgical · 2026 · cites it directly0descendants
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) | K171520 | SteriZign Signatur Device Protection System | Sterizign Precision Technologies, LLC | 2018 | — |
| +1 | K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 4…& Accessories. (21 CFR 880.6850) Class: II Product Code: KCT III. Predicate Devices: Cassettes/trays - K133015 Summit Medical, Instrusafe Instrument Protection System. IV. Description: SteriZign Signatur Device Protection System… | 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 |
|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | 2026 | 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?
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. 2018, 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?
Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. SteriZign Signatur Device Cassette and Trays are used to organize, transport, store and protect between uses of…
Read the full statement (214 words)
Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
SteriZign Signatur Device Cassette and Trays are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Cassette and Trays are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Cassette and Trays are not intended on their own to maintain sterility. SteriZign Signatur Device Cassette and Trays have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.
Autoclave Sterilization Parameter Cycle:
Pre-vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Dry Time: 30 minutes
The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs.
Validated sizes of stainless steel instrument lumens include:
1 each 1mm x 76 mm
1 each 1mm x 400 mm
1 each 2mm x 400 mm
1 each 3mm x 400 mm
1 each 5mm x 400 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171520: SteriZign Signatur Device 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/K171520
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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