FDA product code KQQ: Tubing, Dialysate (And Connector)

KQQ is the FDA product code for tubing, dialysate (and connector). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under KQQ. The average 510(k) review took 44 days (median 44).

Classification

Compare with all 510(k) review times · Search every KQQ clearance

Top KQQ applicants

Most recent KQQ clearances

Recalls for KQQ devices

openFDA lists no recalls for product code KQQ.

Frequently asked questions

What is FDA product code KQQ?

KQQ is the FDA product code for tubing, dialysate (and connector). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.

What device class is KQQ?

Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).

How long does a 510(k) take for product code KQQ?

Across 1 cleared submissions the average was 44 days from receipt to decision (median 44).

Which companies have the most KQQ clearances?

Steridoc Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code KQQ
• Run a recall and safety report across every KQQ manufacturer
• Watch product code KQQ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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