510(k) · Cleared
ClearedSIGMA Sterilization Pouch and Roll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Medical Supplies Corporation · FRG Wrap, Sterilization
Cleared on Apr 23, 2021 as substantially equivalent to K180661 (Sigma Medical Supplies Corp., 2018) after a 239-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Apr 23, 2021
- Review
- 239 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K990567 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 5 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 4 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 3 generations backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 2 generations backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- 1 generation backK180661 SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018
- This deviceK202462 SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −5 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −4 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −3 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −2 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| −1 | K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018 | — |
| 0 (this device) | K202462 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corporation | 2021 | — |
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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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 |
|---|---|---|---|
| * | K180661 | SIGMA Sterilization Pouch and RollSummary page 5…Regulation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800 Predicate Devices The predicate device [510(k) Notification K180661, cleared June 05, 2018] is the SIGMA Sterilization Pouch and Roll. Manufacturer：SIGMA Medical Supplies Corp.… | 2018 |
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K180661.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: * Gravity steam at 121'C (250 0 F) for 30 minutes; Drying time of 30 minutes. * Gravity steam at 132 0 C (270oF) for 15 minutes; Drying time of 30 minutes. * Gravity steam at 135 0 C (275 0 F) for…
Read the full statement (239 words)
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
* Gravity steam at 121'C (250 0 F) for 30 minutes; Drying time of 30 minutes.
* Gravity steam at 132 0 C (270oF) for 15 minutes; Drying time of 30 minutes.
* Gravity steam at 135 0 C (275 0 F) for 10 minutes; Drying time of 30 minutes.
* Pre-vacuum steam at 132 0 C (270'F) for 4 minutes; Drying time of 20 minutes.
* Pre-vacuum steam at 135'C (2750 F) for 3 minutes; Drying time of 16 minutes.
* EO sterilization cycle is 4 hours at 55 0 C (131'F) with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.
Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam 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.
The SIGMA sterilization pouch and roll is offered in the following 6 types:
* Self-sealing sterilization pouches
* Self-sealing sterilization multi pouches
* Sterilization pouches, Flat
* Sterilization pouches, Gusseted
* Sterilization rolls, Flat
* Sterilization rolls, Gusseted
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202462: SIGMA Sterilization Pouch and Roll.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202462
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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