Welch Allyn, Inc.
Welch Allyn Home Blood Pressure Monitor with SureBP (1700 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Extra Small Cuffs (15-24cm)and Extra Large Blood…
Welch Allyn Home Blood Pressure Monitor with SureBP (1700 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Extra Small Cuffs (15-24cm)and Extra Large Blood Pressure Cuffs (40-54cm) are available for purchase. Home Blood Pressure Monitor may be used standalone. or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions.
Who Else Makes It
Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Brav Electronic Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K101680 |
| Record published | 2019-08-07 |
| Record revised | 2022-06-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-08-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901006 | In distribution | |
| 901146 | In distribution | |
| 901146 | In distribution | |
| 901189 | In distribution | |
| 901042 | In distribution | |
| 901146 | In distribution | |
| 901146 | In distribution | |
| 901096 | In distribution | |
| 901097 | In distribution | |
| 901042 | In distribution | |
| 901042 | In distribution | |
| 901146 | In distribution | |
| 901097 | In distribution | |
| 901146 | In distribution | |
| 901097 | In distribution | |
| 901123 | In distribution | |
| 901122 | In distribution | |
| 901097 | In distribution | |
| 901097 | In distribution | |
| 901146 | In distribution | |
| 901043 | In distribution | |
| 901146 | In distribution | |
| 901043 | In distribution | |
| 901146 | In distribution | |
| 901043 | In distribution | |
| 901097 | In distribution | |
| 901122 | In distribution | |
| 901146 | In distribution | |
| 901097 | In distribution | |
| 901043 | In distribution | |
| 901007 | In distribution | |
| 901042 | In distribution | |
| 901097 | In distribution | |
| 901146 | In distribution | |
| 901042 | Withdrawn | |
| 901056 | Withdrawn | |
| 901042 | Withdrawn | |
| 901056 | Withdrawn | |
| 901097 | Withdrawn | |
| 901042 | Withdrawn | |
| 901056 | Withdrawn | |
| 901007 | Withdrawn | |
| 901055 | Withdrawn | |
| 901097 | Withdrawn | |
| 901097 | Withdrawn | |
| 901055 | Withdrawn | |
| 901056 | Withdrawn | |
| 901097 | Withdrawn | |
| 901042 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baum | W.A. Baum Co., Inc. | 116 |
| Alphamed | Shenzhen Urion Technology Co., Ltd. | 68 |
| Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 59 |
| Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd. | 58 |
| A&D Medical | A&D Company, Ltd. | 56 |
| Diagnostix™ | American Diagnostic Corp. | 54 |
| Lutech | Lutech Industries | 51 |
| Veridian | Veridian Healthcare | 50 |
| Hopkins Medical Products® | Hopkins Uniform Company | 49 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 48 |
| SunTech | Suntech Medical, Inc. | 46 |
| System, Measurement, Blood-Pressure, Non-Invasive | Shenzhen Urion Technology Co., Ltd. | 44 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101680 | 2010-07-09 |
| K093907 | 2010-04-14 |
| K052784 | 2005-11-22 |
| K040490 | 2004-08-18 |
| K024005 | 2003-02-12 |
| K023495 | 2002-10-31 |
| K021756 | 2002-06-27 |
| K010186 | 2001-06-08 |
| K001543 | 2001-01-29 |
| K002530 | 2000-11-14 |
| K852574 | 1986-03-13 |
| K781517 | 1979-01-11 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2024-03-26 | Class II | Nonconforming Material/Component | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards. | 11154 units | |
| Welch Allyn, Inc. | 510(k) number | 2021-04-22 | Class II | Device Design | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock | 119770 units | 2024-05-31 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-22 | Class II | Device Design | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock | 789682 | 2024-05-31 |
| 2017-02-27 | Class II | Other | A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This | 981 units | 2019-06-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.