Cleared Traditional

K880391 - DACOMED CYSTOMETER

K880391 is an FDA 510(k) clearance for DACOMED CYSTOMETER, manufactured by Dacomed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code EXQ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K880391 · Dacomed Corp. · Gastroenterology & Urology device
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Apr 1988
Decision
89d
Days
Class 2
Risk

K880391 is an FDA 510(k) clearance for the DACOMED CYSTOMETER. Classified as Cystometer, Electrical Recording (product code EXQ), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dacomed Corp. devices

FDA 510(k) Submission Details - K880391

510(k) Number K880391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1988
Decision Date April 27, 1988
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXQ Device Classification - Class 2, Special Controls

Product Code EXQ Cystometer, Electrical Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EXQ Cystometer, Electrical Recording

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