Clearance details

Applicant: Wolfe Tory Medical, Inc.
Product code: Code BTR
Device class: Class 2
Regulation: 21 CFR 868.5730
Advisory panel: Anesthesiology
Date received: 2002-04-01
Decision date: 2002-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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 Wolfe Tory Medical, Inc.

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K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)2000-09-18
K990556 — ESOPHAGEAL INTUBATION DETECTOR1999-03-26
K945745 — ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)1994-12-07
K942628 — ESOPHAGEAL INTUBATION DETECTOR BULB1994-08-18

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 K021044

K-number listed on FDA's recall record

Z-0385-2017 — LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.Class II·Terminated·Teleflex Medical·20161027

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021044.