510(k) · Cleared
ClearedHALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owens & Minor Halyard, Inc. · FRG Wrap, Sterilization
Cleared on Mar 22, 2019 as substantially equivalent to K142782 (Kimberly-Clark Health Care, 2015) after a 242-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Mar 22, 2019
- Review
- 242 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. 1 later device descends 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 backK142782 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
- This deviceK181959 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Owens & Minor Halyard, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK240330 HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD*…O&M Halyard, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap…O&M Halyard, Inc. · 2024 · 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 | 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 | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 | — |
| 0 (this device) | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | 2019 | — |
| +1 | K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD*… | O&M Halyard, Inc. | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142782 | KIMGUARD ONE-STEP Sterilization WrapSummary page 9…n Wrap Common/Usual Name: Sterilization Wrap Product Code: FRG Proprietary Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650) PREDICATE DEVICE: K142782- KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600) REFERENCE DEVICE: K140963 – KIMGUARD* SMART… | 2015 |
| † | K140963 | Kimguard Smart-Fold Sterilization Wrap | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap… | 2024 | 0 |
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, K240330 (O&M Halyard, Inc., 2024) has gone furthest, with 0 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?
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles: • STERIS V-PRO 1 low temperature sterilization system (lumen cycle), • STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), • STERIS V-PRO maX low…
Read the full statement (147 words)
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles:
• STERIS V-PRO 1 low temperature sterilization system (lumen cycle),
• STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle),
• STERIS V-PRO maX low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle),
• STERIS V-PRO 60 low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle)
• STERIS V-PRO maX 2 low temperature sterilization system (Lumen, Non-Lumen cycle, flexible cycle)
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to allow terminal sterilization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterility of the enclosed device(s) until used within the period of time for which performance data demonstrating maintenance of sterility has been provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181959 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181959: HALYARD SMART-FOLD* Sterilization Wrap (H450, H650).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181959
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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