510(k) · Cleared
Recalled · Class III · 2012Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and Heat Seal Pouches, Heat Seal TU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 19, 2010 as substantially equivalent to K070765 (STERIS Corporation, 2007) and 1 other predicate after a 437-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 19, 2010
- Review
- 437 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771032 (1977). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK771032 Pouches, Peel Open, BreathableSurgicot, Inc. · 1977
- 1 generation backK070765 Vis-U-All II Self Seal PouchSTERIS Corporation · 2007
- This deviceK092745 Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene…STERIS Corporation · 2010
- Descendant · cites it directly · 0 of its ownK231500 Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771032 | Pouches, Peel Open, Breathable | Surgicot, Inc. | 1977 | — |
| −1 | K070765 | Vis-U-All II Self Seal Pouch | STERIS Corporation | 2007 | — |
| 0 (this device) | K092745 | Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide… | STERIS Corporation | 2010 | — |
| +1 | K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K070765 | Vis-U-All II Self Seal PouchSummary page 2…ation Name: Sterilization Wrap (21 CFR 880.6850) Product Code: KCT 2. Predicate Device * Vis-U-All Self Seal Pouch (K070765) * Vis-U-All Heat Seal Pouch and Tubing (K071087) 3. Description of Device The proposed Vis-U-AlI Low Tem… | 2007 |
| * | K071087 | Vis-U-All II Heat-Seal Pouch and TubingSummary page 2…Product Code: KCT 2. Predicate Device * Vis-U-All Self Seal Pouch (K070765) * Vis-U-All Heat Seal Pouch and Tubing (K071087) 3. Description of Device The proposed Vis-U-AlI Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide i… | 2007 |
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 |
|---|---|---|---|
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2012 | Class III | Z-2325-2012 | Nonconforming Material/Component | On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 30.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K231500 (STERIS Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070765.
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. 2010, 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 Vis-U-AI1 Low Temperature Tyvek Sterilization Pouch for ethylene oxide has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-AlI Low Temperature Tyvek Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and…
Read the full statement (166 words)
The Vis-U-AI1 Low Temperature Tyvek Sterilization Pouch for ethylene oxide has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-AlI Low Temperature Tyvek Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Pouch and Tubing Sizes for STERIS Vis-U-All Low Temperature Products
The following are the validation test conditions:
* 1 hour exposure; at 130(+5) OF*, >30% RH using 100% ETO (750-790 mg/L);
* 4.5 hour exposure; at 100(±5) OF*, >30% RIH using 100% ETO (750-790 mg/L);
±5 0F is during sterilization phase following an equilibration period of 10% of exposure time.
The ethylene oxide process indicator is intended to be used by a health care provider with the Vis-U-AlI Low Temperature Tyvek Sterilization Pouches to distinguish between processed and unprocessed units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092745 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092745: Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and Heat Seal Pouches, Heat Seal TU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092745
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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