510(k) · Cleared
ClearedReliance® Fusion Sterilization Wraps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahlstrom-Munksjo Nonwovens, LLC · FRG Wrap, Sterilization
Cleared on Dec 7, 2023 as substantially equivalent to K171533 (Ahlstrom Nonwovens, LLC, 2017) after a 323-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Dec 7, 2023
- Review
- 323 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 backK171533 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017
- This deviceK230137 Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC · 2023
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 | K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap | Ahlstrom Nonwovens, LLC | 2017 | — |
| 0 (this device) | K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | 2023 | — |
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 |
|---|---|---|---|
| * | K171533 | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapSummary page 5…latory Class: 2 Product Code: FRG III. PREDICATE DEVICE Primary Predicate: Reliance® Solo and Reliance® Tandem Sterilization Wrap, K171533 510(k) Device Name Regulation Number and Device Class and… | 2017 |
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 35 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K171533.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: • Pre-vacuum Steam 270°F/132°C for 4 minutes o Dry time of 12 minutes for Fusion Light o Dry time of 20 minutes for Fusion Heavy o Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less. • 100% Ethylene Oxide (EO) with a…
Read the full statement (347 words)
Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
• Pre-vacuum Steam 270°F/132°C for 4 minutes
o Dry time of 12 minutes for Fusion Light
o Dry time of 20 minutes for Fusion Heavy
o Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less.
• 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% - 70% relative humidity for 60 minutes
o Aeration time of 8 hours at 55oC
o Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in length or less.
Table 1: Reliance® Fusion Models and Load Recommendations
Wrap Code | Material Type | Intended Load | Wrap Sheet Size, Maximum Recommended Wrapped Package Content Weight: Pre-Vacuum Steam and Ethylene Oxide¹
Reliance® Fusion Light | Outer SMS / Inner Absorbent Wetlaid Layer | Light to Moderate Weight Package (e.g. general use medical instruments) | 1.8 lb (12" x 12"); 2.0 lb (15" x 15"); 2.4 lb (18" x 18"); 3.2 lb (24" x 24"); 4.3 lb (30" x 30"); 5.7 lb (36" x 36"); 6.7 lb (40" x 40"); 9 lb (48" x 48"); 9 lb (54" x 54"); 9 lb (54" x 72")
Reliance® Fusion Heavy | Outer SMS / Inner Absorbent Wetlaid Layer | Very Heavy Weight Package (e.g. general use medical instruments) | 1.8 lb (12" x 12"); 2.6 lb (15" x 15"); 3.7 lb (18" x 18"); 6.4 lb (24" x 24"); 9.9 lb (30" x 30"); 14.2 lb (36" x 36"); 17.5 lb (40" x 40"); 25 lb (48" x 48"); 25 lb (54" x 54"); 25 lb (54" x 72")
¹ It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. In addition, it is recommended to not exceed the number, weight, and size of individual content types that were validated for Reliance® Fusion Sterilization Wraps (i.e. wrapped contents).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230137: Reliance® Fusion Sterilization Wraps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230137
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