Cleared Traditional

K800234 - ABCO SUCTION CATHETER & KITS W/GLOVE&CUP

K800234 is the FDA 510(k) clearance for ABCO SUCTION CATHETER & KITS W/GLOVE&CUP by Abco Dealers, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K800234 · Abco Dealers, Inc. · General Hospital
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Feb 1980
Decision
21d
Days
Class 2
Risk

K800234 is an FDA 510(k) clearance for the ABCO SUCTION CATHETER & KITS W/GLOVE&CUP. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 21 days - a notably fast clearance 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: 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K800234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1980
Decision Date February 26, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
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 - JOL Catheter And Tip, Suction

All 24
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K800234.
METAL BACKED ACETABULAR COMPONENT
K821342 · Intermedics Orthopedics · May 1982
ARGYLE THORACIC CATHETERS
K820718 · Sherwood Medical Co. · Apr 1982
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · Sherwood Medical Co. · Jan 1981
CONPHAR FINGERTIP SUCTION CONTROL
K791801 · Conphar, Inc. · Sep 1979
HYSTERECTOMY T DRAIN
K782027 · Davol, Inc. · Dec 1978
SUCTION KIT
K760586 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976