510(k) · Cleared
ClearedSterilization Wraps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · FRG Wrap, Sterilization
Cleared on Mar 10, 2022 as substantially equivalent to K182656 (Jiangsu Zhande Medical Supplies Co., Ltd., 2019) after a 51-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Mar 10, 2022
- Review
- 51 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881471 (1988). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 6 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 5 generations backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 4 generations backK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- 3 generations backK141612 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
- 2 generations backK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
- 1 generation backK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
- This deviceK220133 Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −6 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −5 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| −4 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| −3 | K141612 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Health Care | 2014 | — |
| −2 | K160755 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2016 | — |
| −1 | K182656 | JAMBRO Single Core A Sterilization wrap | Jiangsu Zhande Medical Supplies Co., Ltd. | 2019 | — |
| 0 (this device) | K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K182656 | JAMBRO Single Core A Sterilization wrapSummary page 5…e(s) and also to maintain sterility of the enclosed device(s) until used. 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K182656 Product Name: JAMBRO Single Core A Sterilization Wrap Manufacturer: Jiangsu Zhande Medical Supplies Co., Ltd… | 2019 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: * Pre-vacuum steam at 270°F/132°C for 4 minutes Types of medical devices to be sterilized in the pre-vacuum cycle: General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusion-restricted spaces such as forceps and scissors, as well as other general medical instruments…
Read the full statement (149 words)
Sterilization Wraps is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
* Pre-vacuum steam at 270°F/132°C for 4 minutes
Types of medical devices to be sterilized in the pre-vacuum cycle:
General purpose reusable metal and nonmetal devices(No lumen) including devices with stainless steel diffusion-restricted spaces such as forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
The size of the Devices to be sterilized shall allow Sterilization Wraps pack and form a closed space. Validated for dry time is 30 minutes for Sterilization Wraps.
Color of wrap: Blue
Size of wrap: 48 in x 48 in
The maximum validated weight of load for Sterilization Wraps is 12kg.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) 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/K220133 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220133: Sterilization Wraps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220133
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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