Topical Cooling Pad, Model 7000
FDA 510(k) K905568 · Daily Medical Products, Inc.
510(k) numberK905568
Submission
- Device name
- Topical Cooling Pad, Model 7000
- Applicant
- Daily Medical Products, Inc.
San Diego, CA, US - Received
- December 12, 1990
- Decision date
- January 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
More from Quest Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914005 | Fiberoptic Tympanic Thermometer, Model 6000FLL · Traditional | 07/30/1992SE |
| K905652 | Myocardial Temperature Monitoring Probes, CJ-1000FLL · Traditional | 02/14/1991SE |
| K896975 | Cardiac Cooling Jacket, 30% Reduced, Model CJ-220DWC · Traditional | 02/05/1990SE |
| K896974 | Cardiac Cooling Jacket, 8 CM, Model CJ-120DWC · Traditional | 02/05/1990SE |
| K896973 | Cardiac Cooling Jacket, 30% Enlarged, Model CJ-320DWC · Traditional | 02/05/1990SE |
| K896972 | Cardiac Cooling Jacket, 12 CM, Model CJ-520DWC · Traditional | 02/05/1990SE |
| K896971 | Cardiac Cooling Jacket, 8 CM, Model CJ-420DWC · Traditional | 02/05/1990SE |
Questions and answers
When was Topical Cooling Pad, Model 7000 cleared by the FDA?
Topical Cooling Pad, Model 7000 (K905568) received a 510(k) decision of Substantially Equivalent on January 23, 1991, 42 days after the submission was received.
What is the product code of K905568?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.