Cleared Traditional

K883474 - THORACIC CATHETERS

K883474 is an FDA 510(k) clearance for THORACIC CATHETERS, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K883474 · Westmark, Sterile Packing Systems, Inc. (Sps) · General & Plastic Surgery device
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Sep 1988
Decision
28d
Days
Class 1
Risk

K883474 is an FDA 510(k) clearance for the THORACIC CATHETERS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 28 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K883474

510(k) Number K883474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date September 13, 1988
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 41
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K883474.
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K870704 · American Pharmaseal Div. Ahsc · Mar 1987
MICROTEK IRRIGATION SYSTEM
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VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985