Cleared Traditional

K922349 - DOWD(TM) II

K922349 is an FDA 510(k) clearance for DOWD(TM) II, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K922349 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
87d
Days
Class 2
Risk

K922349 is an FDA 510(k) clearance for the DOWD(TM) II. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 14, 1992 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 876.5520 - 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K922349

510(k) Number K922349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date August 14, 1992
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 - KOE Dilator, Urethral

All 21
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K922349.
BARD EAGLE INFLATION DEVICE
K962611 · Ryder Intl. Corp. · Oct 1996
AQ HYDROPHILIC DILATORS
K961904 · Cook Urological, Inc. · Oct 1996
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · American Medical Systems, Inc. · Oct 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · American Medical Systems, Inc. · May 1992
APEX(TM) PROSTATIC BALLOON DILATION CATHETER
K913477 · Peripheral Systems Group · Dec 1991
AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990