Welch Allyn, Inc.
Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer with 4-6 Second Oral, 10-13 Second Rectal and Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in…
Welch Allyn SureTemp Plus 692 Wall-Mount Electronic Thermometer with 4-6 Second Oral, 10-13 Second Rectal and Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in Fahrenheit or Celsius; Interchangeable Rectal Probe Well, Rectal Probe with 9.0 ft/2.7 m Cord, Last Temperature Recall, 60-Second Pulse/Respiration Timer, Backlit Display with Electronic ID, Anti-Theft Security System; 3 Alkaline AA Batteries; Multiple Language
Who Else Makes It
Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Famidoc Technology Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 6 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | FLL |
| Device type | Continuous Measurement Thermometer |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2910 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K152748 |
| Record published | 2017-12-05 |
| Record revised | 2025-08-14 (version 12) |
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 10, pack of 4, pack of 30 |
| Distribution end date | 2025-11-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901113 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901010 | 20 | In distribution | |
| 901054 | In distribution | ||
| 901053 | In distribution | ||
| 901113 | In distribution | ||
| 901053 | In distribution | ||
| 901113 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901113 | In distribution | ||
| 901053 | In distribution | ||
| 901094 | In distribution | ||
| 901053 | In distribution | ||
| 901122 | In distribution | ||
| 901010 | In distribution | ||
| 901053 | In distribution | ||
| 901010 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901121 | In distribution | ||
| 901010 | In distribution | ||
| 901054 | In distribution | ||
| 901010 | 25 | In distribution | |
| 901054 | In distribution | ||
| 901113 | In distribution | ||
| 901009 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901010 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901054 | In distribution | ||
| 901053 | In distribution | ||
| 901094 | In distribution | ||
| 901053 | In distribution | ||
| 901012 | In distribution | ||
| 901009 | In distribution | ||
| 901010 | In distribution | ||
| 901010 | In distribution | ||
| 901122 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901010 | In distribution | ||
| 901043 | In distribution | ||
| 901010 | In distribution | ||
| 901010 | 20 | In distribution | |
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901053 | In distribution | ||
| 901012 | In distribution | ||
| 901054 | In distribution | ||
| 901010 | In distribution | ||
| 901012 | In distribution | ||
| 901010 | 25 | Withdrawn | |
| 901054 | Withdrawn | ||
| 901012 | Withdrawn | ||
| 901054 | Withdrawn | ||
| 901009 | Withdrawn | ||
| 901011 | Withdrawn | ||
| 901053 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 434 |
| Safety 1st | Dorel Juvenile Group, Inc. | 180 |
| Diagnostix™ | American Diagnostic Corp. | 61 |
| DeRoyal | Deroyal Industries, Inc. | 58 |
| Braun | KAZ USA, Inc. | 53 |
| Exergen Temporal Scanner | Exergen Corporation | 50 |
| Level 1 | ICU Medical, Inc | 48 |
| Famidoc | Famidoc Technology Co., Ltd. | 47 |
| Adtemp™ | American Diagnostic Corp. | 35 |
| TempTraq | Blue Spark Technologies, Inc. | 35 |
| Medline | Medline Industries, Inc. | 34 |
| Mabis | D-M-S Holdings, Inc. | 34 |
Showing 12 of 843. All products under Continuous Measurement Thermometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030580 | 2003-05-06 |
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 |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2024-06-13 | Class II | Process control | The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). | 265,647 units |
| Welch Allyn, Inc. | 510(k) number | 2021-07-20 | Class II | Labeling design | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient | 1,036,740 units |
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 |
|---|---|---|---|---|---|
| 2003-12-30 | Not classified | Other | Mechanical setting errors that result in calibration errors. | 4453 | 2004-07-21 |
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.