510(k) · Cleared
ClearedSigma Sterilization Pouch & Roll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Medical Supplies Corp. · FRG Wrap, Sterilization
Cleared on Aug 2, 2011 as substantially equivalent to K070428 (A.R. Medicom, Inc., 2007) and 1 other predicate after a 368-day review. Its family tree reaches back 4 generations to 1999. 16 later devices descend from it.
- Decided
- Aug 2, 2011
- Review
- 368 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990567 (1999). 16 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 3 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 2 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 1 generation backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- This deviceK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- Descendant · cites it directly · 5 of its ownK212338 SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021
- Descendant · cites it directly · 4 of its ownK143637 U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK221875 Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK180661 SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018
- Descendant · 2 generations on · 1 of its ownK162258 Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021 · cites it directly5descendants
- K143637U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd. · 2015 · cites it directly4descendants
- K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023 · 2 generations on3descendants
- K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp. · 2018 · cites it directly2descendants
- K162258Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −3 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −2 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −1 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| 0 (this device) | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| +1 | K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021 | — |
| +1 | K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015 | — |
| +2 | K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023 | — |
| +1 | K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018 | — |
| +2 | K162258 | Self Sealing Sterilization Pouches | Tianchang Jiarui Packaging Material Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K070428 | Medicom Self-Sealing Sterilization PouchSummary page 2…Standard 1) ANSIIAAMvIIISO 11607-1:2006 (KCT) 2) ISO 11140-1:2005 (JOJ) 2. Predicate Devices 0 K070428, Medicom Self Sealing - Sterilization Pouch, Product Code [KCT; JOY] * K05J1242, Winner® Self Seal Sterilization pouch, Produ… | 2007 |
| * | K051242 | Winner Self Seal Sterilization PouchSummary page 7…tertlizatuan. ouch 510(k) Number K(102158 K070428 K(051242 Material Medical Grade Papar, CPP, PET, PU MedalGrade PaperCPP,… | 2005 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212338 | SterileRight sterilization pouch and roll | 2021 | 5 |
| K143637 | U&U Sterilization Pouch and Roll | 2015 | 4 |
| K180661 | SIGMA Sterilization Pouch and Roll | 2018 | 2 |
| K162362 | PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator | 2017 | 0 |
| K152669 | PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) | 2016 | 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?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K212338 (Sterileright Packaging Mfg., Inc., 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K070428.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121tC. The recommended EO sterilization cycle is 4 hours at 551C with a relative humidity between 50O/o 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization…
Read the full statement (142 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 steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121tC. The recommended EO sterilization cycle is 4 hours at 551C with a relative humidity between 50O/o 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years 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.
The SIGMA sterilization pouch and roll is offered in the following 5 types:
* Self-sealing sterilization pouches
* Sterilization pouches, Flat
* Sterilization pouches, Gusseted
* Sterilization rolls, Flat
* Sterilization rolls, Gusseted
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102158: Sigma Sterilization Pouch & Roll.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102158
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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