Cleared Traditional

STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (K895039) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895039 · Aplicare, Inc. · General Hospital
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Oct 1989
Decision
55d
Days
Class 2
Risk

K895039 is an FDA 510(k) clearance for the STERILE SALINE - FOR SUCTION CATHETER LUBRICATION. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Aplicare, Inc. (Madison, US). The FDA issued a Cleared decision on October 3, 1989 after a review of 55 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 Aplicare, Inc. devices

Submission Details

510(k) Number K895039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1989
Decision Date October 03, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 12
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K895039.
CODMAN SUCTION PATTIE
K901937 · Codman & Shurtleff, Inc. · Jul 1990
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · Abbott Laboratories · Aug 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · Abbott Laboratories · Mar 1989
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982