HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
FDA 510(k) K200319 · Deroyal Industries, Inc.
510(k) numberK200319
Submission
- Device name
- HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- February 7, 2020
- Decision date
- April 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
Other 510(k)s with product code FMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
| K230278 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 05/30/2023SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | Deroyal Industries, Inc. | 01/21/2020SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
| K121625 | Lullaby TM WarmerFMT · Traditional | Wipro GE Healthcare Private, Ltd. | 09/14/2012SE |
More from Wipro GE Healthcare Private, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | 11/21/2025SE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | 04/18/2024SE |
| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | 12/23/2020SE |
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | 10/15/2020SE |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | 01/21/2020SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
| K142962 | PROTOCOL Incision DressingFRO · Traditional | 07/23/2015SE |
Questions and answers
When was HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable cleared by the FDA?
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (K200319) received a 510(k) decision of Substantially Equivalent on April 2, 2020, 55 days after the submission was received.
What is the product code of K200319?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.