Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BTR
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Date received: 1979-10-10
Decision date: 1979-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Recent devices under product code BTR

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K251794 — Tenax® Laser Resistant Endotracheal Tube2026-09-03
K253437 — Spiro-VISTA2026-06-12
K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)2025-10-06
K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced2025-09-25
K243579 — AeroJet Ventilation Catheter2025-08-13

More clearances from Bivona Medical Technologies

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K952700 — SUPERSLICK1995-10-31
K942025 — BURGET NASAL STENT1995-10-27
K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES1994-10-27
K935053 — BIVONA NASAL TURBINATE STENT1994-07-01
K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE1993-10-06

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K792035

K-number listed on FDA's recall record

Z-0177-2022 — Bivona Aire-Cuf Endotracheal TubeClass II·Terminated·Smiths Medical ASD Inc.·20210809
Z-0178-2022 — Bivona Uncuffed Wire Endotracheal Tubes,Class II·Terminated·Smiths Medical ASD Inc.·20210809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K792035.