Cleared Traditional

K952414 - PREFILLED SYRINGE FOR INFLATION OF FOLE...

K952414 is an FDA 510(k) clearance for PREFILLED SYRINGE FOR INFLATION OF FOLE..., manufactured by Acacia Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K952414 · Acacia Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
31d
Days
Class 2
Risk

K952414 is an FDA 510(k) clearance for the PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Acacia Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 23, 1995 after a review of 31 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 Acacia Laboratories, Inc. devices

FDA 510(k) Submission Details - K952414

510(k) Number K952414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1995
Decision Date June 23, 1995
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K952414.
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