Cleared Traditional

K944119 - SURE-FLO IRRIGATION Y TUBING SET

K944119 is an FDA 510(k) clearance for SURE-FLO IRRIGATION Y TUBING SET, manufactured by O.R. Resources, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K944119 · O.R. Resources, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
104d
Days
Class 2
Risk

K944119 is an FDA 510(k) clearance for the SURE-FLO IRRIGATION Y TUBING SET. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by O.R. Resources, Inc. (Annapolis, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all O.R. Resources, Inc. devices

FDA 510(k) Submission Details - K944119

510(k) Number K944119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1994
Decision Date December 05, 1994
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 47
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K944119.
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
K974038 · A & A Medical, Inc. · May 1998
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
K963558 · Contemporary Products, Inc. · Dec 1996
VACPLUS
K945062 · Kinetic Concepts, Inc. · Mar 1995
ANNELID
K940886 · Kinetic Concepts, Inc. · Nov 1994
SUCTION TUBES: HOUSE, BARON
K930030 · Thomasville Medical Assoc. · Feb 1994
COOK ASPIRATION UNIT
K930900 · Cook Ob/Gyn · Jul 1993