Cleared Traditional

K844876 - PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,

K844876 is an FDA 510(k) clearance for PENNINE NELATON CATHETERS SIZES 5, manufactured by Pennine Medical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K844876 · Pennine Medical , Ltd. · General & Plastic Surgery device
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Jun 1985
Decision
170d
Days
Class 1
Risk

K844876 is an FDA 510(k) clearance for the PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Pennine Medical , Ltd. (Derby, GB). The FDA issued a Cleared decision on June 5, 1985 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pennine Medical , Ltd. devices

FDA 510(k) Submission Details - K844876

510(k) Number K844876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 05, 1985
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
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 - GBX Catheter, Irrigation

All 50
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K844876.
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · Arrow Intl., Inc. · Dec 1989
THORACIC CATHETERS
K883474 · Westmark, Sterile Packing Systems, Inc. (Sps) · Sep 1988
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
MICROTEK IRRIGATION SYSTEM
K844061 · Microtek Medical, Inc. · May 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984