Cleared Traditional

K800235 - ABCO CONNECTING TUBES PRECUT LENGTHS

K800235 is an FDA 510(k) clearance for ABCO CONNECTING TUBES PRECUT LENGTHS, manufactured by Abco Dealers, Inc.. The device is a Class 2 General Hospital device with product code BYY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K800235 · Abco Dealers, Inc. · General Hospital
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Feb 1980
Decision
21d
Days
Class 2
Risk

K800235 is an FDA 510(k) clearance for the ABCO CONNECTING TUBES PRECUT LENGTHS. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), 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.

FDA 510(k) Submission Details - K800235

510(k) Number K800235 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.

BYY Device Classification - Class 2, Special Controls

Product Code BYY Tube, Aspirating, Flexible, Connecting
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 - BYY Tube, Aspirating, Flexible, Connecting

All 23
Devices cleared under the same product code (BYY) and FDA review panel - the closest regulatory comparables to K800235.
AM. PH. STERILE PLASTIC CONNECTING TUBES
K820412 · American Pharmaseal Div. Ahsc · Mar 1982
CONNECTING TUBE
K813228 · Northern Medical Industries · Nov 1981
MGN CONNECTING TUBE
K811541 · Mgn Medical Manufacturing, Inc. · Jun 1981
YANKAUER & POODLE SUCTION INSTRUMENTS
K790419 · Snyder Laboratories, Inc. · Apr 1979
SUCTION CONNECTING TUBING
K790420 · Snyder Laboratories, Inc. · Apr 1979
BUBBLE SUCTION TUBING
K780724 · Davol, Inc. · Jun 1978
K800235 · ABCO CONNECTING TUBES PRECUT LENGTHS
Download PDF Abco Dealers, Inc.