Cleared Traditional

K974295 - BYRON MEDICAL ASPIRATION AND INFILTRATI...

K974295 is an FDA 510(k) clearance for BYRON MEDICAL ASPIRATION AND INFILTRATI..., manufactured by Byron Medical. The device is a Class 1 General & Plastic Surgery device with product code KGZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974295 · Byron Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
88d
Days
Class 1
Risk

K974295 is an FDA 510(k) clearance for the BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Byron Medical devices

FDA 510(k) Submission Details - K974295

510(k) Number K974295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1997
Decision Date February 10, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KGZ Device Classification - Class 1, General Controls

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGZ Accessories, Catheter

All 13
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K974295.
PALESTRANT IRRIGATION AND DRAINAGE SET
K896087 · North American Instrument Corp. · Nov 1989
CONCEPT SWITCHING STICK
K873009 · Concept, Inc. · Aug 1987
DESERET UNIVERSAL LUER LOCK
K821525 · Warner-Lambert Co. · Jun 1982
DESERET OFFSET PRN ADAPTER
K821245 · Warner-Lambert Co. · May 1982
PERI-PATCH GLUE MOLD
K810530 · Quinton, Inc. · Mar 1981
PERI-PATCH PERITONEAL CATHETER EXTENSION
K810531 · Quinton, Inc. · Mar 1981