Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
FDA 510(k) clearance K234032 · decided 2024-06-04
Clearance details
- K-number
- K234032
- Device name
- Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
- Applicant
- Medline Industries, LP
- Decision
- Substantially Equivalent
- Date received
- 2023-12-20
- Decision date
- 2024-06-04
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Northfiled, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.