Cleared Traditional

K851385 - THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE

K851385 is the FDA 510(k) clearance for THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE by Gesco Intl., Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K851385 · Gesco Intl., Inc. · General Hospital
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May 1985
Decision
44d
Days
Class 2
Risk

K851385 is an FDA 510(k) clearance for the THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 44 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K851385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date May 23, 1985
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 16
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K851385.
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · Arrow Intl., Inc. · Jan 1989
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K870572 · Arrow Intl., Inc. · May 1987
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · Sherwood Medical Co. · Aug 1983
METAL BACKED ACETABULAR COMPONENT
K821342 · Intermedics Orthopedics · May 1982
ARGYLE THORACIC CATHETERS
K820718 · Sherwood Medical Co. · Apr 1982