BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
FDA 510(k) clearance K173384 · decided 2018-04-10
Clearance details
- K-number
- K173384
- Device name
- BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
- Applicant
- Smiths Medical Ads, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-30
- Decision date
- 2018-04-10
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, recall (Z-3086-2024) | Smiths Medical ASD Inc. | 2024-09-11 |
| smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect trac recall (Z-3087-2024) | Smiths Medical ASD Inc. | 2024-09-11 |
| smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect trach recall (Z-3088-2024) | Smiths Medical ASD Inc. | 2024-09-11 |