510(k) · Cleared
ClearedHALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
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 Aug 7, 2024 as substantially equivalent to K181959 (Owens & Minor Halyard, Inc., 2019) after a 184-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Aug 7, 2024
- Review
- 184 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K881471 (1988). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK881471 Kimguard (Regular & Heavy Duty) Sterile WrapKimberly-Clark Corp. · 1988 · Recalled
- 5 generations backK082177 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2009
- 4 generations backK091685 Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300…Kimberly-Clark Corp. · 2009
- 3 generations backK112805 Kimguard One-Step Sterilization WrapKimberly-Clark Corp. · 2012
- 2 generations backK142782 KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care · 2015
- 1 generation backK181959 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Owens & Minor Halyard, Inc. · 2019
- This deviceK240330 HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD*…O&M Halyard, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881471 | Kimguard (Regular & Heavy Duty) Sterile Wrap | Kimberly-Clark Corp. | 1988 | 1 |
| −5 | K082177 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2009 | — |
| −4 | K091685 | Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC… | Kimberly-Clark Corp. | 2009 | — |
| −3 | K112805 | Kimguard One-Step Sterilization Wrap | Kimberly-Clark Corp. | 2012 | — |
| −2 | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 | — |
| −1 | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Summary page 5…Wrap (H650) Common Name: Sterilization Wrap Classification Name: Sterilization wrap (21 CFR 880.6850, Product Code FRG) Predicate Device: K181959 (SMART-FOLD Sterilization Wrap) Reference Device: K140963 (SMART-FOLD Sterilization Wrap) Device Description: H… | 2019 |
| † | K140963 | Kimguard Smart-Fold Sterilization Wrap | 2014 |
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 36 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle. The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows: • Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no…
Read the full statement (187 words)
HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to
be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI
Cycle.
The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the
STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen
dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs),
one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable.
Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes
The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed
medical device(s) and to maintain sterility of the enclosed device(s) until used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240330: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240330
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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