Level 1 Convective Warmer
FDA 510(k) K181699 · Smiths Medical Asd, Inc.
510(k) numberK181699
Submission
- Device name
- Level 1 Convective Warmer
- Applicant
- Smiths Medical Asd, Inc.
Minnepolis, MN, US - Received
- June 27, 2018
- Decision date
- July 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
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Questions and answers
When was Level 1 Convective Warmer cleared by the FDA?
Level 1 Convective Warmer (K181699) received a 510(k) decision of Substantially Equivalent on July 26, 2018, 29 days after the submission was received.
What is the product code of K181699?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.