Cleared Traditional

K980946 - MARK II CO2 FLUSH MANOMETRIC PERFUSION ...

K980946 is an FDA 510(k) clearance for MARK II CO2 FLUSH MANOMETRIC PERFUSION ..., manufactured by Dentsleeve Pty., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980946 · Dentsleeve Pty., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
87d
Days
Class 2
Risk

K980946 is an FDA 510(k) clearance for the MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Dentsleeve Pty., Ltd. (Parkside South Australia, AU). The FDA issued a Cleared decision on June 8, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 Dentsleeve Pty., Ltd. devices

FDA 510(k) Submission Details - K980946

510(k) Number K980946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1998
Decision Date June 08, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 - FFX System, Gastrointestinal Motility (electrical)

All 19
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K980946.
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