Cleared Traditional

K892549 - SUCTION TUBES: HOUSE

K892549 is the FDA 510(k) clearance for SUCTION TUBES: HOUSE by Zinnanti Surgical Instruments, Inc.. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K892549 · Zinnanti Surgical Instruments, Inc. · General Hospital
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May 1989
Decision
37d
Days
Class 2
Risk

K892549 is an FDA 510(k) clearance for the SUCTION TUBES: HOUSE, BARON. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 37 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K892549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 18, 1989
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K892549.
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
MECONIUM ASPIRATOR
K893649 · Gish Biomedical, Inc. · Aug 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
K890129 · Deknatel, Inc. · Apr 1989
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
K890431 · Deknatel, Inc. · Apr 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · Abbott Laboratories · Mar 1989