K-number	K251950
Device name	Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
Applicant	Hangzhou Tappa Medical Technology Co., Ltd.
Product code	CBI
Device class	Class II
Decision date	Mar 20, 2026
Decision	Substantially Equivalent
Regulation	868.5740

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Endobronchial Blocker Tube is a single-use sterile medical device designed to isolate either the left or right lung during surgical procedures requiring one-lung ventilation. It works by differentially intubating a patient's bronchus and is available in multiple sizes (5Fr, 7Fr, 9Fr) with the 5Fr variant indicated for pediatric patients weighing at least 10 kg and all other sizes for adult use only.

Technological characteristics

The device features an angled tip, polyamide tube material, silicone cuff/balloon, silicone suction port, and ethylene oxide sterilization. Key differences from predicates include length variations (5Fr: 450mm, 7Fr: 550mm, 9Fr: 550mm) and cylindrical cuff shape with volume limits (5Fr ≤2cc, 7Fr ≤3cc, 9Fr ≤4.5cc). The EBT01 series lacks an auto-inflator while EBT02 series includes one.

Test standards cited

Testing per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity), ISO 18562 series (breathing gas pathways biocompatibility), ISO 11135 and 10993-7 (ethylene oxide sterilization), ISO 5361 and 16628 (tracheal/tracheobronchial tubes), ASTM F1980 and D4169 (shelf-life and packaging), and USP pyrogen testing.

Substantial equivalence argument

The proposed device has identical intended use and substantially similar technological characteristics (design, materials, outer diameter, sterilization method) to legally marketed predicates (Arndt and COOPDECH endobronchial blockers). Non-clinical testing demonstrates equivalent safety and effectiveness; minor differences in cuff shape, volume, and length do not affect clinical performance or raise new safety concerns, as positioning and inflation are guided by fibroscopic visualization and physician judgment.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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