Thermostat 900 Administration Set, Model Ash 100, 200 and 300
FDA 510(k) K073363 · Paladin Biomedical Corporation
510(k) numberK073363
Submission
- Device name
- Thermostat 900 Administration Set, Model Ash 100, 200 and 300
- Applicant
- Paladin Biomedical Corporation
Weston, MA, US - Received
- November 30, 2007
- Decision date
- March 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260988 | °M Warmer System with °M StationLGZ · Special | Mequ A/S | 04/24/2026SE |
| K252636 | Fluido Compact SystemLGZ · Traditional | The Surgical Company International B.V. | 11/18/2025SE |
| K251733 | Fluido® AirGuard SystemLGZ · Traditional | The Surgical Company International BV (As Tsc… | 09/04/2025SE |
| K232107 | °M Warmer SystemLGZ · Traditional | Mequ A/S | 05/31/2024SE |
| K211618 | Fluido Compact Blood and Fluid Warming SystemLGZ · Traditional | The Surgical Company International B.V. | 06/05/2023SE |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite…LGZ · Traditional | Quality IN Flow , Ltd. | 12/08/2022SE |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemLGZ · Traditional | Smisson-Cartledge Biomedical, LLC | 08/12/2022SE |
| K213191 | S-LineLGZ · Traditional | Barkey GmbH & Co. KG | 05/24/2022SE |
| K192325 | Quantum Blood and Fluid Warming SystemLGZ · Special | Life Warmer, Inc. | 10/18/2019SE |
| K180842 | MAC Medical D-Series Blanket and Solution Warming CabinetsLGZ · Traditional | Mac Medical, Inc. | 03/05/2019SE |
Questions and answers
When was Thermostat 900 Administration Set, Model Ash 100, 200 and 300 cleared by the FDA?
Thermostat 900 Administration Set, Model Ash 100, 200 and 300 (K073363) received a 510(k) decision of Substantially Equivalent on March 20, 2008, 111 days after the submission was received.
What is the product code of K073363?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.