Data / Medical devices / United States / HR PHARMACEUTICALS, INC d/b/a HR HealthCare
HR PHARMACEUTICALS, INC d/b/a HR HealthCare: FDA-registered device maker in York, PA, United States, 15 510(k) clearances
HR PHARMACEUTICALS, INC d/b/a HR HealthCare is registered with the FDA (registration 3008502431) in York, PA, United States. It lists 23 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 24, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008502431
- Address
- 3630 Concord Rd, York, PA, United States, 17402
- Owner or operator
- HR Pharmaceuticals, Inc d/b/a HR HealthCare (10032609)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 28, 2010
- Registered through
- 2026
- Brand names listed
- HR Lubricating Jelly
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 24, 2026 | K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | EZD | Substantially Equivalent | Hangzhou Jimushi Meditech Co., Ltd. | accessdata.fda.gov |
| March 12, 2026 | K260502 | Liv Pre-lubricated Intermittent Catheter | EZD | Substantially Equivalent | HR Healthcare | accessdata.fda.gov |
| January 29, 2026 | K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | EZD | Unknown | HR Healthcare | accessdata.fda.gov |
| April 5, 2023 | K222677 | Intermittent nelaton catheter for single use | EZD | Substantially Equivalent | Hangzhou Jimushi Meditech Co., Ltd. | accessdata.fda.gov |
| April 8, 2021 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | Substantially Equivalent | Well Lead Medical Co., Ltd. | accessdata.fda.gov |
| March 31, 2020 | K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | EZL | Substantially Equivalent | H R Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 13, 2018 | K173340 | Yikang Latex Foley Catheter | EZL | Substantially Equivalent | Jiangxi Yikang Medical Instrument Group Co., Ltd. | accessdata.fda.gov |
| June 13, 2018 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | MUI | Substantially Equivalent | H R Pharmaceuticals, Inc. | accessdata.fda.gov |
| November 15, 2017 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution | FRO | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. | accessdata.fda.gov |
| October 3, 2013 | K130908 | DISPOSABLE SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Guangdong Baihe Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| July 17, 2008 | K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | KOD | Substantially Equivalent | Medical Technologies of Georgia, Inc. | accessdata.fda.gov |
| February 4, 2004 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| October 20, 1997 | K970893 | ULTRASOUND TRANSDUCER DRAPE | FYA | Substantially Equivalent | Protek Medical Products, Inc. | accessdata.fda.gov |
| November 30, 1994 | K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | EZL | Substantially Equivalent | Medical Technology Development Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Catheter, Ureteral, Gastro-Urology
- All makers of Catheter, Straight
- All makers of Lubricant, Vaginal, Patient
- All makers of Catheter, Retention Type, Balloon
- All makers of Dressing, Wound, Occlusive
Updated June 24, 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.