510(k) · Cleared
ClearedSterileRight sterilization pouch and roll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterileright Packaging Mfg., Inc. · FRG Wrap, Sterilization
Cleared on Nov 1, 2021 as substantially equivalent to K102158 (Sigma Medical Supplies Corp., 2011) after a 97-day review. Its family tree reaches back 5 generations to 1999. 5 later devices descend from it.
- Decided
- Nov 1, 2021
- Review
- 97 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990567 (1999). 5 later devices descend from it, 2 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 backK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
- 1 generation backK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
- This deviceK212338 SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc. · 2021
- Descendant · cites it directly · 3 of its ownK221875 Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251347 Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251177 Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241565 Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242898 Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd. · 2023 · cites it directly3descendants
- K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K241565Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd. · 2025 · cites it directly0descendants
- K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd. · 2025 · 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 | K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | 2007 | — |
| −1 | K102158 | Sigma Sterilization Pouch & Roll | Sigma Medical Supplies Corp. | 2011 | — |
| 0 (this device) | K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021 | — |
| +1 | K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023 | — |
| +2 | K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026 | — |
| +2 | K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | 2025 | — |
| +1 | K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025 | — |
| +2 | K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K102158 | Sigma Sterilization Pouch & RollSummary page 5…II Regulation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800 Predicate Devices The predicate device [510(k) Notification K102158, cleared August 02, 2011] is the SIGMA Sterilization Pouch and Roll. Page 1 of 12 ===… | 2011 |
What descends from it? (5)
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 22 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221875 (Qianjiang Kingphar Medical Packaging & Printing Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K102158.
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 SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: * Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. * Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. * Ethylene Oxide (EO) with a concentration of 735…
Read the full statement (230 words)
The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to
enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles
are as follows:
* Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
* Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
* 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 60°C (140°F).
The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.
The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for
up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the
date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also
maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a
maximum shelf life of 3 years from the date of manufacture.
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/K212338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212338: SterileRight 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/K212338
Report an extraction error
Are you the manufacturer?
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