Product code BTS— Anesthesiology

FDA has cleared 6 devices under product code BTS between 1977 and 1995, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19952 clearances
• 19901 clearance
• 19841 clearance
• 19831 clearance
• 19771 clearance

• Surgitek1 clearance
• Rusch Intl.1 clearance
• Rusch, Inc.1 clearance
• Portex, Inc.1 clearance
• Mallinckrodt Critical Care1 clearance
• Concord/Portex1 clearance

Death

2

Malfunction

877

Total

879

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 →

• K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONRusch, Inc.·1995-11-27
• K951091 — RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.·1995-06-08
• K902116 — MODIFIED ENDOBRONCHIAL TUBEConcord/Portex·1990-08-03
• K834565 — ENDOBRONCHIAL TWIN LUMEN TUBEPortex, Inc.·1984-01-17
• K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFFSurgitek·1983-12-27
• K771219 — BRONCHO-CATHMallinckrodt Critical Care·1977-08-04