Cleared Traditional

K981229 - MANAN MANTA CATHETER FIXATION DISK

K981229 is an FDA 510(k) clearance for MANAN MANTA CATHETER FIXATION DISK, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K981229 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
19d
Days
Class 2
Risk

K981229 is an FDA 510(k) clearance for the MANAN MANTA CATHETER FIXATION DISK. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on April 22, 1998 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K981229

510(k) Number K981229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date April 22, 1998
Days to Decision 19 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 131d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 46
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K981229.
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · Medical Device Technologies, Inc. · Apr 1999
SNAP-N-PEEL INTRODUCERS
K981611 · Circon Corp. · Jul 1998
HYDROPHILIC COATED GUIDEWIRE
K981667 · Lake Region Mfg., Inc. · Jun 1998
INSULATOR WIRE GUIDE
K972977 · Cook Urological, Inc. · Oct 1997
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
K960866 · Lake Region Mfg., Inc. · Apr 1996
MANAN MANTA CATHETER FIXATION DISK
K954132 · Manan Medical Products, Inc. · Mar 1996