Cleared Traditional

K854812 - NELSON-JUNG PLEURAL CATH

K854812 is an FDA 510(k) clearance for NELSON-JUNG PLEURAL CATH, manufactured by Research Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K854812 · Research Medical, Inc. · General & Plastic Surgery device
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Feb 1986
Decision
70d
Days
Class 1
Risk

K854812 is an FDA 510(k) clearance for the NELSON-JUNG PLEURAL CATH. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K854812

510(k) Number K854812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date February 11, 1986
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

GBW Device Classification - Class 1, General Controls

Product Code GBW Catheter, Peritoneal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBW Catheter, Peritoneal

All 13
Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K854812.
MEDIASTINAL SILICONE DRAINS
K942709 · Sil-Med Corp. · Jan 1996
ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
K933510 · Sherwood Medical Co. · Feb 1994
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
K926477 · Core Dynamics, Inc. · Nov 1993
DERBYSHIRE DRAIN
K843575 · Sil-Med Corp. · Oct 1984
FLAT DRAIN
K813063 · Sil-Med Corp. · Dec 1981
ARROW PERITONEAL LAVAGE CATHERIZATION K
K811627 · Arrow Intl., Inc. · Aug 1981