510(k) · Cleared
ClearedHalyard ONE-STEP* Sterilization Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owens & Minor (O&M) Halyard, Inc. · FRG Wrap, Sterilization
Cleared on Oct 10, 2019 as substantially equivalent to K141712 (Halyard Health, 2014) after a 63-day review. Its family tree reaches back 5 generations to 1988. 4 later devices descend from it.
- Decided
- Oct 10, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881471 (1988). 6 ancestors in all. 4 later devices descend from it, 1 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 backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 2 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- 1 generation backK141712 Kimguard One Step Sterilization WrapHalyard Health · 2014
- This deviceK192147 Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK214007 HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK…Owens & Minor (O&M) Halyard, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK234050 HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK®…O&M Halyard, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261897 HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology…O&M Halyard, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK253454 HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK*…O&M Halyard, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc. · 2022 · cites it directly3descendants
- K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc. · 2024 · 2 generations on2descendants
- K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc. · 2026 · 3 generations on0descendants
- K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc. · 2026 · 3 generations on0descendants
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 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −2 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| −1 | K141712 | Kimguard One Step Sterilization Wrap | Halyard Health | 2014 | — |
| 0 (this device) | K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019 | — |
| +1 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2022 | — |
| +2 | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization… | O&M Halyard, Inc. | 2024 | — |
| +3 | K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*… | O&M Halyard, Inc. | 2026 | — |
| +3 | K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization… | O&M Halyard, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K141712 | Kimguard One Step Sterilization WrapSummary page 4…ilizat ion Wra pWrap· K14 17- 12 K141712 Device Description Device Description: : Ha lya ONE-STEP• Halyard ONE… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | 2022 | 3 |
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 31 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K214007 (Owens & Minor (O&M) Halyard, Inc., 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC…
Read the full statement (277 words)
The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below:
Lumen Cycle:
Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:
Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are:
≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long;
and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load).
Flexible Cycle:
Reusable rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long.
(Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192147 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192147: Halyard ONE-STEP* Sterilization Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192147
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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