510(k) · Cleared
ClearedReliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahlstrom Nonwovens, LLC · FRG Wrap, Sterilization
Cleared on Jul 27, 2016 as substantially equivalent to K082177 (Kimberly-Clark Corp., 2009) and 7 other predicates after a 131-day review. Its family tree reaches back 5 generations to 1988. 6 later devices descend from it.
- Decided
- Jul 27, 2016
- Review
- 131 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K881471 (1988). 9 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 4 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 3 generations backK092167 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 2 generations backK113806 Kimguard One Step Sterilization WrapKimberly-Clark Health Care · 2013
- 1 generation backK141612 Kimguard One-Step Sterilization WrapKimberly-Clark Health Care · 2014
- This deviceK160755 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2016
- Descendant · cites it directly · 2 of its ownK171533 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017
- Descendant · cites it directly · 1 of its ownK182656 JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK240438 CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ®…Comercializadora Brever · 2024
- Descendant · 2 generations on · 0 of its ownK230137 Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC · 2023
- Descendant · cites it directly · 0 of its ownK223600 Sterilization WrapWuhan Zonsen Medical Products Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC · 2017 · cites it directly2descendants
- K182656JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd. · 2019 · cites it directly1descendant
- K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever · 2024 · 2 generations on0descendants
- K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC · 2023 · 2 generations on0descendants
- K223600Sterilization WrapWuhan Zonsen Medical Products Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −4 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −3 | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… | Kimberly-Clark Corp. | 2009 | — |
| −2 | K113806 | Kimguard One Step Sterilization Wrap | Kimberly-Clark Health Care | 2013 | — |
| −1 | K141612 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Health Care | 2014 | — |
| 0 (this device) | 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 | — |
| +1 | K182656 | JAMBRO Single Core A Sterilization wrap | Jiangsu Zhande Medical Supplies Co., Ltd. | 2019 | — |
| +2 | K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap… | Comercializadora Brever | 2024 | — |
| +2 | K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | 2023 | — |
| +1 | K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (8)
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 |
|---|---|---|---|
| * | K082177 | Kimguard One-Step Sterilization WrapSummary page 6…e: FRG Regulation Number: 880.6850 III. PREDICATE DEVICE The Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, cleared under K082177 is the primary predicate device utilized in this submission. The following 510(k) numbers, also referencing the Kimberly… | 2009 |
| * | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600Summary page 6…the Kimberly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related r… | 2009 |
| * | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600Summary page 6…erly Clark Kimguard® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall.… | 2009 |
| * | K141071 | Kimguard One-Step Sterilization WrapSummary page 6…k Kimguard® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall. No r… | 2014 |
| * | K092167 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600Summary page 6…d® and Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall. No reference… | 2009 |
| * | K112805 | Kimguard One-Step Sterilization WrapSummary page 6…Kimguard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall. No reference devices w… | 2012 |
| * | K113806 | Kimguard One Step Sterilization WrapSummary page 6…uard® ONE-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall. No reference devices were used… | 2013 |
| * | K141612 | Kimguard One-Step Sterilization WrapSummary page 6…-STEP® sterilization wraps, are utilized as secondary predicate devices for this submission: • K082554, K091685, K141071, K092167, K112805, K113806, K141612 These predicate devices have not been subject to a design-related recall. No reference devices were used in this s… | 2014 |
What descends from it? (6)
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)
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 28 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K171533 (Ahlstrom Nonwovens, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K082177.
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
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?
Ahlstrom Reliance® Tandem and Solo 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 • Gravity Steam 250°F/121°C for 30 minutes • 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes • Advanced Sterilization Products (ASP) STERRAD® 100S • Advanced…
Read the full statement (746 words)
Ahlstrom Reliance® Tandem and Solo 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
• Gravity Steam 250°F/121°C for 30 minutes
• 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% - 80% relative humidity for 60 minutes
• Advanced Sterilization Products (ASP) STERRAD® 100S
• Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
• STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Pre-Vacuum Steam Sterilization:
• Validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300.
• Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600.
• All models of Reliance® Tandem and Solo validated for pre-vacuum steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
Gravity Steam Sterilization:
• Validated for dry times of 20 minutes for Models T100/S100, T200/S200, T300/S300.
• Validated for dry times of 30 minutes for Models T400/S400.
• Models T100/S100, T200/S200, T300/S300, T400/S400 of Reliance® Tandem and Solo validated for gravity steam sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
• Models T500/S500 and T600/S600 are not validated for use for gravity steam sterilization.
Ethylene Oxide Sterilization:
• Validated for aeration time of 8 hours at 55°C
• All models of Reliance® Tandem and Solo validated for ethylene oxide sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization
• All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100S sterilization with stainless steel lumens (2 mm inside diameter or larger and a length of 250mm or less) as part of the load with a maximum weight of 10.7lbs dependent on the model.
Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization
• All models of Reliance® Tandem and Solo validated with ASP STERRAD® 100NX sterilization cycles detailed in Table 1.
Table 1: Validated Advanced Sterilization Products (ASP) STERRAD® 100NX Cycles
Advanced Sterilization Products (ASP) STERRAD® System and Cycle Intended Load
100NX Standard Cycle Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load:
• An inside diameter of 0.7mm or larger and a length of 500mm or shorter of single-channel stainless steel lumens.
100NX Flex Cycle One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain:
• A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850mm or shorter. (A maximum of two flexible endoscopes, one per tray per sterilization cycle)
100NX Express Cycle Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens.
STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems
• All models of Reliance® Tandem and Solo Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed in Table 2.
• Reliance® Tandem and Solo Sterilization Wraps were validated to be effectively aerated during the pre-programmed STERIS Amsco V-PRO® Sterilization Cycles.
Table 2: Validated STERIS Amsco® V-PRO Cycles
STERIS Amsco® V-PRO Cycle Intended Load
Lumen Cycle Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter.
Non Lumen Cycle Non lumened reusable metal and non-metal medical devices.
Flexible Cycle Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration:
1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 1 mm or larger and a length of 850 mm or shorter.
2.) An additional tray containing non-lumened medical devices.
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/K160755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160755
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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