BIVONA TRACHEOSTOMY TUBES— 510(k) K083641
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K083641 for BIVONA TRACHEOSTOMY TUBES, Substantially Equivalent on 2009-02-23. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code JOH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gary, IN, US
Recent devices under product code JOH
view all- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- K203362 — TRACOE vario
- K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
More clearances from Smiths Medical Asd, Inc.
view all- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K181699 — Level 1 Convective Warmer
- K172800 — Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K083641
K-number listed on FDA's recall record- Z-0205-2024 — Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
- Z-2946-2020 — Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
- Z-1465-2017 — Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083641.
Data sourced from openFDA. This site is unofficial and independent of the FDA.