510(k) · Cleared
ClearedHALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · FRG Wrap, Sterilization
Cleared on Jul 2, 2026 as substantially equivalent to K234050 (O&M Halyard, Inc., 2024) after a 27-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Jul 2, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881471 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 7 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 6 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 5 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- 4 generations backK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
- 3 generations backK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
- 2 generations backK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
- 1 generation backK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
- This deviceK261897 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology…O&M Halyard, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −7 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −6 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −5 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| −4 | K141712 | Kimguard One Step Sterilization Wrap | Halyard Health | 2014 | — |
| −3 | K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019 | — |
| −2 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2022 | — |
| −1 | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization… | O&M Halyard, Inc. | 2024 | — |
| 0 (this device) | K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*… | O&M Halyard, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…Summary page 8…chnology Common Name: Sterilization Wrap Classification Name: Sterilization wrap (21 CFR 880.6850, Product Code FRG) Predicate Device: K234050 (HALYARD* ONE-STEP* Sterilization Wrap, HALYARD* QUICK CHECK* Sterilization Wrap, and HALYARD* SEQUE… | 2024 |
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 38 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K234050.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology, STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, and H300W Sterilization Wrap with ASSURE-DRY * Technology are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * Pre-vacuum steam * The wrap was validated for dry times of 20 minutes with the…
Read the full statement (187 words)
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology, STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY * Technology, and H300W Sterilization Wrap with ASSURE-DRY * Technology are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
* Pre-vacuum steam
* The wrap was validated for dry times of 20 minutes with the moisture managing amber layer on the inside, and for 30 minutes with the moisture managing amber layer on the outside.
* 270°F/132°C for 4 minutes
* 270°F/132°C for 10 minutes
* 273.2°F/134°C for 3 minutes
* 273.2°F/134°C for 18 minutes
* 275°F/135°C for 3 minutes
» STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.
* STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
* STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)
* STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycles)
* STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycles)
» Advanced Sterilization Products STERRAD® Sterilization System
* STERRAD® 100NX® (Standard Cycle)
* STERRAD® 100NX® with ALLClear® Technology (Standard Cycle)
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/K261897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261897: HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261897
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026