510(k) · Cleared
ClearedMedicom Self-Sealing Sterilization Pouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.R. Medicom, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 17, 2007 as substantially equivalent to K051242 (Winner Medical (Usa), Inc., 2005) after a 154-day review. Its family tree reaches back 3 generations to 1999. 19 later devices descend from it.
- Decided
- Jul 17, 2007
- Review
- 154 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990567 (1999). 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 2 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 1 generation backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- This deviceK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- Descendant · cites it directly · 16 of its ownK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- Descendant · 2 generations on · 5 of its ownK212338 SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK143637 U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015
- Descendant · 3 generations on · 3 of its ownK221875 Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK180661 SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011 · cites it directly16descendants
- K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021 · 2 generations on5descendants
- K143637U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015 · 2 generations on4descendants
- K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023 · 3 generations on3descendants
- K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −2 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −1 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| 0 (this device) | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| +1 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| +2 | K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021 | — |
| +2 | K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015 | — |
| +3 | K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023 | — |
| +2 | K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 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 |
|---|---|---|---|
| * | K051242 | Winner Self Seal Sterilization PouchSummary page 1…Recognized Performance Standard ISO 11140-1:2005 (JOJ) 5.4 Predicate Devices Winner® Self Seal Sterilization pouch 510(k) Number K051242 5.5 Intended Use The self-sealing sterilization pouches are int… | 2005 |
What descends from it? (19)
See all 192 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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102158 (Sigma Medical Supplies Corp., 2011) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K051242.
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. 2007, 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 self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the…
Read the full statement (110 words)
The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070428: Medicom Self-Sealing Sterilization Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070428
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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