510(k) · Cleared
ClearedSafe Secure Sterilization Pounch 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 Feb 7, 2012 as substantially equivalent to K062704 (Winner Industries (Shenzhen) Co., Ltd., 2007) and 1 other predicate after a 153-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Feb 7, 2012
- Review
- 153 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990567 (1999). 6 later devices descend from it, 2 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 backK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
- This deviceK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK153540 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK180139 Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK250306 Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243431 Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025
- Descendant · 3 generations on · 0 of its ownK242839 Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. · 2016 · cites it directly4descendants
- K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd. · 2019 · 2 generations on1descendant
- K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc. · 2025 · 2 generations on0descendants
- K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. · 2025 · 2 generations on0descendants
- K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2024 · 3 generations on0descendants
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 | K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | 2007 | — |
| 0 (this device) | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process… | Safe Secure Packaging Co., Ltd. | 2012 | — |
| +1 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | Safe Secure Packaging Co., Ltd. | 2016 | 43 |
| +2 | K180139 | Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. | 2019 | — |
| +2 | K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025 | — |
| +2 | K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K062704 | Sterilization Pouch with IndicatorsSummary page 2…inner Compny Medical USA, Inc. Address: 1900-H Proforma Ave. Ontario, CA 92861 51 0(k)i number: K(062704 Device Name: STERILIZATION POUCH WITH INDICATORS… | 2007 |
| * | K051242 | Winner Self Seal Sterilization PouchSummary page 2…ility of the enclosed device until used. NameWinner Medical USA, Inc. Compan Address. 1900-H Proforma Ave. Ontario, CA 92861 510k number K(051242 Device Name: WINNER SELF SEAL STERILIZATION POUICH… | 2005 |
What descends from it? (6)
2 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 13 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K153540 (Safe Secure Packaging Co., Ltd., 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide. (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 1210 C (250 ofl. The recommended EtO gas sterilization cycle is l35mgJL of ethylene oxide (EtO) for 1 hour at 550C (130 0 F) and 50% to…
Read the full statement (137 words)
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide. (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 1210 C (250 ofl. The recommended EtO gas sterilization cycle is l35mgJL of ethylene oxide (EtO) for 1 hour at 550C (130 0 F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=1 0-) of the enclosed device until used.
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/K112591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112591
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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