Clearance details

Applicant: Flexicare Medical, Ltd.
Product code: Code BTR
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Date received: 2009-06-02
Decision date: 2009-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mid Glamorgan, GB

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 Flexicare Medical, Ltd.

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K150900 — Flexicare Heated Wire Breathing Systems2015-05-15
K140473 — DUALGUARD2014-04-10
K140113 — O2 NASAL CANNULA WITH CO2 MONITORING2014-03-06
K132619 — CLASSIC INTERMITTENT CATHETER2013-10-11
K092218 — FLEXICARE BREATHING FILTERS2009-10-06

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 K091591

K-number listed on FDA's recall record

Z-0497-2021 — ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customersClass I·Terminated·Flexicare Medical Ltd.·20200922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091591.