HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050)
Description
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap by O&M Halyard, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234050
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050) cites 10 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SM... | O&M Halyard, Inc. | 2024 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK St... | Owens & Minor (O&M) Halyard, Inc. | 2022 |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | 2019 |
| K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | Owens & Minor Halyard, Inc. | 2019 |
| K143053 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | 2015 |
| K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | Halyard Health | 2014 |
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | Kimberly-Clark Corp. | 2014 |
| K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014 |
| K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | Kimberly-Clark Health Care | 2014 |
Trace the full predicate network for K234050
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.