Cleared Traditional

K930512 - SUCTION/IRRIGATION Y TUBING SET W/TRUMP...

K930512 is an FDA 510(k) clearance for SUCTION/IRRIGATION Y TUBING SET W/TRUMP..., manufactured by Core Dynamics, Inc.. The device is a Class 2 General Hospital device with product code GAZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K930512 · Core Dynamics, Inc. · General Hospital
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Jul 1993
Decision
172d
Days
Class 2
Risk

K930512 is an FDA 510(k) clearance for the SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 23, 1993 after a review of 172 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K930512

510(k) Number K930512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date July 23, 1993
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAZ Device Classification - Class 2, Special Controls

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GAZ Tubing, Noninvasive

All 13
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K930512.
SUCTION/IRRIGATOR TUBING KIT
K952605 · Surgical Laser Technologies, Inc. · Sep 1995
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
K910471 · Baxter Healthcare Corp · Mar 1991
SURGICAL CONNECTING TUBES
K883473 · Westmark, Sterile Packing Systems, Inc. (Sps) · Aug 1988
5 - IN - 1 CONNECTOR
K864964 · Medovations, Inc. · Jan 1987
STERILE 5 IN 1 CONNECTORS
K830835 · Abco Dealers, Inc. · Apr 1983
STERILE SAFETY PINS
K830381 · Devon Industries, Inc. · Mar 1983