Cleared Traditional

K820004 - PLEUROFIX THORACENTESIS KIT

K820004 is the FDA 510(k) clearance for PLEUROFIX THORACENTESIS KIT by Burron Medical Products, Inc.. It is a Class 2 General Hospital device (product code GAZ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K820004 · Burron Medical Products, Inc. · General Hospital
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Feb 1982
Decision
31d
Days
Class 2
Risk

K820004 is an FDA 510(k) clearance for the PLEUROFIX THORACENTESIS KIT. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 31 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K820004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1982
Decision Date February 04, 1982
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAZ Tubing, Noninvasive
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.