Class Class II
Heated Breathing Tube (K243244)
Description
Heated Breathing Tube by Guangdong Eda Technology Co., Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243244
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeBZE
Regulation Number868.5270
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243244
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Heated Breathing Tube (K243244) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-11... | Joytech Healthcare Co. , Ltd. | 2025 |
| K110860 | COMP A-I-R | Omron Healthcare, Inc. | 2011 |
Trace the full predicate network for K243244
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.