Cleared Traditional

K893649 - MECONIUM ASPIRATOR

K893649 is an FDA 510(k) clearance for MECONIUM ASPIRATOR, manufactured by Gish Biomedical, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K893649 · Gish Biomedical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
98d
Days
Class 2
Risk

K893649 is an FDA 510(k) clearance for the MECONIUM ASPIRATOR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K893649

510(k) Number K893649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 21, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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 - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 50
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K893649.
YANKAUER SUCTION TUBE-RIGID TYPE
K896558 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
STOPCOCK
K896562 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TUBING CONNECTORS
K896563 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
SUCTION TUBES: HOUSE, BARON
K892549 · Zinnanti Surgical Instruments, Inc. · May 1989
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
K890129 · Deknatel, Inc. · Apr 1989