Cleared Traditional

K832865 - FLEX BUBBLE TUBING

K832865 is an FDA 510(k) clearance for FLEX BUBBLE TUBING, manufactured by Sheridan Catheter Corp.. The device is a Class 2 General Hospital device with product code BYY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K832865 · Sheridan Catheter Corp. · General Hospital
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Sep 1983
Decision
37d
Days
Class 2
Risk

K832865 is an FDA 510(k) clearance for the FLEX BUBBLE TUBING. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 37 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 Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K832865

510(k) Number K832865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1983
Decision Date September 29, 1983
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 11
Devices cleared under the same product code (BYY) and FDA review panel - the closest regulatory comparables to K832865.
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K922989 · Wiltek Medical, Inc. · Feb 1994
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
K911586 · Megadyne Medical Products, Inc. · Jul 1991
PHARMA-PLAST CONNECTING TUBE TYPE SUCT-
K843470 · Zimmar Consulting , Ltd. · Nov 1984
DYNACOR CONNECTING TUBING
K832398 · Medline Industries, Inc. · Aug 1983
PLASTIC TUBING CONNECTORS
K831920 · Polymer Technology Corp. · Jul 1983
PLASTIC CONNECTORS
K820371 · American Pharmaseal Div. Ahsc · Apr 1982