Temp. Sensor W/22MM Fittings
FDA 510(k) K780260 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK780260
Submission
- Device name
- Temp. Sensor W/22MM Fittings
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- February 15, 1978
- Decision date
- March 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPD – Strip, Temperature, Forehead, Liquid Crystal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2200
- Specialty
- General Hospital
Other 510(k)s with product code KPD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934941 | E-Z Temp IIKPD · Traditional | Seven C'S, Inc. | 07/27/1994SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | Marquest Medical Products, Inc. | 08/17/1990SE |
| K893803 | Fever Line and Fever Line PlusKPD · Traditional | Liquid Crystal Sciences, Inc. | 08/21/1989SE |
| K864853 | Omni Therm Temperature MonitorKPD · Traditional | Omni Therm, Inc. | 02/04/1987SE |
| K850797 | Tempalert Liquid Crystal ThermometerKPD · Traditional | Medical Frontiers, Inc. | 04/05/1985SE |
| K841913 | Temptrend Peds Axillary Temp. IndicatorKPD · Traditional | Biosynergy, Inc. | 11/02/1984SE |
| K833904 | Temptrend IIKPD · Traditional | Biosynergy, Inc. | 12/27/1983SE |
| K832651 | Ati Forehead ThermometerKPD · Traditional | American Thermal Instruments, Inc. | 10/04/1983SE |
| K823221 | Acca-Temp Skin Temp. Vinyl DiscKPD · Traditional | T. G. & E. Medical | 01/12/1983SE |
| K821312 | Temptrend Temperature Trend IndicatorKPD · Traditional | Liquid Crystal Products, Inc. | 05/28/1982SE |
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
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Questions and answers
When was Temp. Sensor W/22MM Fittings cleared by the FDA?
Temp. Sensor W/22MM Fittings (K780260) received a 510(k) decision of Substantially Equivalent on March 14, 1978, 27 days after the submission was received.
What is the product code of K780260?
The FDA product code is KPD – Strip, Temperature, Forehead, Liquid Crystal, a Class II (moderate risk) device regulated under 21 CFR 880.2200.