ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR— 510(k) K790312

Clearance details

Applicant

Respiratory Support Products, Inc.

Product code

Code BTR

Device class

Class 2

Regulation

21 CFR 868.5730

Advisory panel

Anesthesiology

Date received

1979-02-13

Decision date

1979-02-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• 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

• K983862 — CLOUD 1 HUMIDIFICATION SYSTEM1999-05-24
• K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER1993-03-09
• K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE1992-09-11
• K921510 — GAS SAMPLING KIT MODIFICATION1992-06-11
• K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D1991-12-11

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 →

• Z-1289-2025 — Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035Class I·Ongoing·Smiths Medical ASD, Inc.·20250213
• Z-2536-2014 — 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation KitClass I·Terminated·Smiths Medical ASD, Inc.·20140707
• Z-2537-2014 — H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation KitClass I·Terminated·Smiths Medical ASD, Inc.·20140707
• Z-2538-2014 — H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation KitClass I·Terminated·Smiths Medical ASD, Inc.·20140707
• Z-2539-2014 — H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation KitClass I·Terminated·Smiths Medical ASD, Inc.·20140707
• Z-1641-2014 — Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.Class I·Terminated·Smiths Medical ASD, Inc.·20140410

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K790312.