Data / Medical devices / United States / Halyard North Carolina, LLC
Halyard North Carolina, LLC: FDA-registered device maker in Linwood, NC, United States, 19 510(k) clearances
Halyard North Carolina, LLC is registered with the FDA (registration 1054380) in Linwood, NC, United States. It lists 4 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1054380
- FEI number
- 1000110722
- Address
- 389 Clyde Fitzgerald RD, Linwood, NC, United States, 27299
- Owner or operator
- O&M Halyard, Inc. (10057479)
- Roles
- Manufacturer
- First device listed
- May 2, 2018
- Registered through
- 2026
- Brand names listed
- DISPOSABLE MEDICAL BEDDING, EXAMINATION GOWN, HALYARD PROCEDURE GOWN, HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology, HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY*Technology, HALYARD* ONE-STEP* Sterilization Wrap, HALYARD* QUICK CHECK* Sterilization Wrap, HALYARD* SEQUENTIAL Sterilization Wrap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 2, 2026 | 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 | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| May 18, 2026 | K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| September 16, 2024 | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| July 27, 2022 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | FRG | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| October 10, 2019 | K192147 | Halyard ONE-STEP* Sterilization Wrap | FRG | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| April 3, 2015 | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| March 9, 2015 | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| December 18, 2014 | K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| November 10, 2014 | K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| August 7, 2014 | K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| July 28, 2014 | K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| August 20, 2013 | K113806 | KIMGUARD ONE STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| June 22, 2012 | K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| January 19, 2012 | K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| November 2, 2009 | K092167 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| September 3, 2009 | K091685 | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| May 1, 2009 | K082554 | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 27, 2009 | K082177 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| August 10, 1988 | K881471 | KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Bedding, Disposable, Medical
- All makers of Accessory, Surgical Apparel
- All makers of Gown, Examination
Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.