Cleared Traditional

K881981 - ASSIST(TM) ASEPTIC SYRINGE IRRIGATION S...

K881981 is the FDA 510(k) clearance for ASSIST(TM) ASEPTIC SYRINGE IRRIGATION S... by Ryder Intl. Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K881981 · Ryder Intl. Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
82d
Days
Class 2
Risk

K881981 is an FDA 510(k) clearance for the ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Ryder Intl. Corp. (Columbus, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 82 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 Ryder Intl. Corp. devices

Submission Details

510(k) Number K881981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date August 02, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 116
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K881981.
KENDALL CURITY IRRIGATION SYRINGE
K892436 · The Kendal Co. · Jul 1989
CATHETERS, MALE, FEMALE
K892691 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CATHETER STRAP
K881781 · Baxter Healthcare Corp · Aug 1988
SYRINGE PREFILLED WITH WATER
K881363 · I M, Inc. · Jun 1988
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · Cook Urological, Inc. · Mar 1988
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER
K874112 · Van-Tec, Inc. · Feb 1988