Welch Allyn, Inc.
Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with…
Welch Allyn 767 Integrated Wall Diagnostic System including Wall Aneroid Sphygmomanometer (#7670-01), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), Pneumatic Otoscope (#20200), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in /86.4 x 30.5
50manufacturers in China registered for this device type
1,310catalogue numbers in this listing
4510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Guangdong (22), Zhejiang (13), Jiangsu (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| A&D Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Suntech Medical Devices (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shanghai Minhua Medical Apparatus Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Wenzhou Naisi Health Product Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 50. All 50 manufacturers in China registered for Blood Pressure Cuff
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | DXQ |
| Device type | Blood Pressure Cuff |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1120 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051904 |
| Record published | 2023-04-26 |
| Record revised | 2025-04-25 (version 27) |
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 |
| Packaging | Pack of 20, pack of 5, pack of 40, pack of 10, pack of 2, pack of 6 |
| Distribution end date | 2025-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901044 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 1,801 |
| Diagnostix™ | American Diagnostic Corp. | 681 |
| Orantech | Orantech Inc. | 648 |
| Blood Pressure Cuff | Salter Labs | 425 |
| Aneroids (82 etc.) | Rashman Corp. | 418 |
| Medline | Medline Industries, Inc. | 390 |
| Baum | W.A. Baum Co., Inc. | 349 |
| Adcuff™ | American Diagnostic Corp. | 348 |
| Disposable cuff | Suntech Medical, Inc. | 326 |
| Vistarmed | Shenzhen Vistar Medical Supplies Co., Ltd. | 254 |
| Statcorp Medical | Statcorp, Inc. | 229 |
| All Purpose Cuff | Suntech Medical, Inc. | 202 |
Showing 12 of 598. All products under Blood Pressure Cuff
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122058 | 2012-11-05 |
| K070060 | 2007-12-18 |
| K012455 | 2001-08-17 |
| K940493 | 1994-07-01 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2025-03-21 | Class II | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | 385920 units | |
| Baxter Healthcare Corporation | UDI-DI | 2025-03-21 | Class II | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | 76407 units | |
| Suntech Medical, Inc. | 510(k) number | 2019-06-03 | Class II | Labeling Change Control | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package. | 80 total cuffs affected; 4 Boxes of 20 cuffs | 2020-12-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2004-03-01 | Not classified | Other | GMP deficiencies | 2005-09-01 | |
| 2003-10-27 | Not classified | Other | Incorrect location of inflatable portion of cuff that may result in cuff falling off patient’s arm, error code when used with patient monitor, or an inaccurate reading. | 26190 | 2005-09-01 |
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.