Cleared Traditional

K760333 - JAR

K760333 is the FDA 510(k) clearance for JAR by Harris-Lake, Inc.. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K760333 · Harris-Lake, Inc. · General Hospital
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Oct 1976
Decision
90d
Days
Class 2
Risk

K760333 is an FDA 510(k) clearance for the JAR, COLLECTOR FOR SUCTION SYSTEMS. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Harris-Lake, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1976 after a review of 90 days - within the typical 510(k) review window.

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 Harris-Lake, Inc. devices

Submission Details

510(k) Number K760333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1976
Decision Date October 27, 1976
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 26
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K760333.
ARGYLE COMPACT CHEST DRAINAGE SYS.
K802440 · Sherwood Medical Co. · Oct 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · Sherwood Medical Co. · Sep 1980
TUBING, DYNACOR UNIVERSAL
K790055 · Medline Industries, Inc. · Feb 1979
SUCTION INSTRUMENT, MACBICK POOLE TIP
K760216 · C.R. Bard, Inc. · Aug 1976
SUCTION INSTRUMENT, MACBICK DIS. FRAZ.
K760217 · C.R. Bard, Inc. · Aug 1976