FDA cleared the 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) from Flexicare Medical Limited. on Sep 2, 2026 under K254026, a traditional 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.
FDA logged the submission as received on Dec 16, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Flexicare Medical Limited. has one other decision in the tracker over the last 12 months: K251448 (FL-10000U Respiratory Humidifier).
Questions & Answers
What did FDA clear under K254026?
K254026 is the FDA 510(k) for 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U), submitted by Flexicare Medical Limited.. FDA's decision date was Sep 2, 2026, under product code EOQ (Bronchoscope (Flexible Or Rigid)).
Who makes the 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)?
Flexicare Medical Limited., based in Rhondda Cynon Taf, is the applicant of record for K254026.
How long did the K254026 review take?
FDA received the submission on Dec 16, 2025 and issued its decision on Sep 2, 2026, 260 days later.