Electronic Thermometers
510(k) K940686
Electronic Thermometers is a Class II device made by American Diagnostic Corp., cleared under FDA 510(k) K940686 on 8 Jul 1994, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940686 | Date8 Jul 1994 | StatusActive |
Official records
- FDA 510(k) database K940686
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLL
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K940686
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Adtemp™ 412-00 | 412-00 / 412-00 | 00634782048549 | On the market | |
| Adtemp™ 412K | 412K / 412K | 00634782048556 | On the market | |
| Adtemp™ 413B | 413B / 413B | 00634782053598 | On the market | |
| Adtemp™ 413B-00 | 413B-00 / 413B-00 | 00634782053604 | On the market | |
| Adtemp™ 413BK | 413BK / 413BK | 00634782053611 | On the market | |
| Adtemp™ 413BQ | 413BQ / 413BQ | 00634782082987 | On the market | |
| Adtemp™ 413BRKIT | 413BRKIT / 413BRKIT | 00634782063658 | On the market | |
| Adtemp™ 413R | 413R / 413R | 00634782053628 | On the market | |
| Adtemp™ 413R-00 | 413R-00 / 413R-00 | 00634782053635 | On the market | |
| Adtemp™ 413RK | 413RK / 413RK | 00634782053642 | On the market | |
| Adtemp™ 413RQ | 413RQ / 413RQ | 00634782082994 | On the market | |
| Adtemp™ 416-100 | 416-100 / 416-100 | 00634782002534 | On the market | |
| Adtemp™ 416-1000 | 416-1000 / 416-1000 | 00634782002541 | On the market | |
| Adtemp™ 416-50 | 416-50 / 416-50 | 00634782053673 | On the market | |
| Adtemp™ 416-5000 | 416-5000 / 416-5000 | 00634782548292 | On the market | |
| Dual Scale Digital Thermometer 16809 | 16809 / 16809 | 00612606001505 | On the market | |
| Henry Schein 9004856 | 9004856 / 9004856 | 00304040000908 | On the market | |
| Hopkins 410HOP | 410HOP / 410HOP | 00634782033125 | On the market | |
| HOPKINS 416-100HOP | 416-100HOP / 416-100HOP | 00634782047726 | On the market | |
| McKesson 01-412GM-00 | 01-412GM-00 | 20612479134724 | On the market | |
| McKesson 01-413BGM | 01-413BGM | 10612479128085 | On the market | |
| McKesson 01-413BGM-00 | 01-413BGM-00 | 20612479134755 | On the market | |
| McKesson 01-413BKGM | 01-413BKGM | 10612479134772 | On the market | |
| McKesson 01-413RGM | 01-413RGM | 10612479128092 | On the market | |
| McKesson 01-413RGM-00 | 01-413RGM-00 | 20612479134816 | On the market | |
| McKesson 01-413RKGM | 01-413RKGM | 10612479134833 | On the market | |
| Moore Medical 63347 | 63347 | 20607415001192 | No longer on the market | |
| Moore Medical 72746 | 72746 | 10607415001171 | No longer on the market | |
| Oral Temperature Digital Thermometer 16811 | 16811 / 16811 | 00612606001512 | On the market | |
| Oral Temperature Digital Thermometer 16812 | 16812 / 16812 | 00612606001529 | On the market | |
| Pro Advantage P541222 | P541222 / P541222 | M220P5412220 | On the market | |
| Rectal Digital Thermometer 16816 | 16816 / 16816 | 00612606001543 | On the market | |
| Rectal Temperature Digital Thermometer 16813 | 16813 / 16813 | 00612606001536 | On the market |
Similar devices
Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).
- Ear Thermometer, Model ET001 by Guangzhou Berrcom Medical Device Co., Ltd
- RII Multi-function Infrared Thermometer, Model TH52Z by Radiant Innovation Inc.
- 3M SPOTON TEMPERATURE MONITORING SYSTEM by Arizant Healthcare, Inc.
- Flexible Tip Digital Thermometer by K-jump Health Co., Ltd.
- INFRARED EAR THERMOMETER, MODEL IR-04MT by VEGA TECHNOLOGIES INC.
- Sterile Disposable Temperature Probe by Shenzhen Envisen Industry Co., Ltd.
- INFRARED EAR THERMOMETER, MODEL DX-707 by Jawon Medical Co., Ltd.
- WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H by Rio Flexon Technology Co., Ltd.
- Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) by DONGGUAN E-TEST TECHNOLOGY CO., LTD
- MODEL 4070 TEMPERATURE MONITOR by Mallinckrodt Anesthesia Products