510(k) · Cleared
Recalled · Class II · 2020Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safe Secure Packaging Co., Ltd. · FRG Wrap, Sterilization
Cleared on Aug 4, 2016 as substantially equivalent to K112591 (Safe Secure Packaging Co., Ltd., 2012) after a 238-day review. Its family tree reaches back 5 generations to 1999. 4 later devices descend from it. It has been recalled 43 times.
- Decided
- Aug 4, 2016
- Review
- 238 days
- Class
- Class II
- Product code
- FRG
- Recalls
- 43
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990567 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 4 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 3 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 2 generations backK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
- 1 generation backK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
- This deviceK153540 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK180139 Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK250306 Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243431 Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025
- Descendant · 2 generations on · 0 of its ownK242839 Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019 · cites it directly1descendant
- K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025 · cites it directly0descendants
- K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025 · cites it directly0descendants
- K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −4 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −3 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −2 | K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | 2007 | — |
| −1 | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process… | Safe Secure Packaging Co., Ltd. | 2012 | — |
| 0 (this device) | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | 2016 | — |
| +1 | K180139 | Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. | 2019 | — |
| +1 | K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025 | — |
| +1 | K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025 | — |
| +2 | K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSummary page 6…: II Classification Panel: General Hospital Model Numbers: ABHSP, ABSSP, ABHST, ABSST 5.5 Predicate Devices K112591 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators… | 2012 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2020 | Class II | Z-0787-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained… |
| Dec 2, 2020 | Class II | Z-0796-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0798-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0799-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0786-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0791-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0792-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0793-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0795-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0797-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0790-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0794-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0788-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Dec 2, 2020 | Class II | Z-0789-2021 | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s)… |
| Jun 15, 2017 | Class II | Z-0744-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0745-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0748-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0749-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0753-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0761-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0764-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0770-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0751-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0752-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0758-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0759-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0760-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0762-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0765-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0766-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0771-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0747-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0750-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0757-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0763-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0768-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0743-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0746-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0754-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0755-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0756-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0767-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
| Jun 15, 2017 | Class II | Z-0769-2018 | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of… |
The 5 latest of 43 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180139 (Safe Secure Packing Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K112591.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2007high 12 (2015) · low 2 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
2007high 260 (2017) · low 110 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
2007high 29 (2017) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
2007high 22 (2018) · low 0 (2010)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?
Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: • Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time • Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time • Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time • Pre-vacuum steam at 135°C (275°F)…
Read the full statement (279 words)
Safe Secure Paper Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).
The device is not intended and has not been validated for sterilization of devices that contain lumens.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam and from yellow to brown after exposure to ethylene oxide.
The Tyvek version of the pouch is for EO sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10 -6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization and 24 months after EO sterilization.
The maximum validated pouch load is 2.64 pounds (1.2kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153540
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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