Cleared Traditional

SUCTION APPARATUS, POWERED BY COMP. AIR (K781988) - FDA 510(k) Clearance

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

K781988 · Farley, W.T. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
15d
Days
Class 2
Risk

K781988 is an FDA 510(k) clearance for the SUCTION APPARATUS, POWERED BY COMP. AIR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Farley, W.T. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1978 after a review of 15 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 Farley, W.T. devices

Submission Details

510(k) Number K781988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date December 12, 1978
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 14
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K781988.
ARGYLE COMPACT CHEST DRAINAGE SYS.
K802440 · Sherwood Medical Co. · Oct 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · Sherwood Medical Co. · Sep 1980
TUBING, DYNACOR UNIVERSAL
K790055 · Medline Industries, Inc. · Feb 1979
SUCTION INSTRUMENT, MACBICK POOLE TIP
K760216 · C.R. Bard, Inc. · Aug 1976
SUCTION INSTRUMENT, MACBICK DIS. FRAZ.
K760217 · C.R. Bard, Inc. · Aug 1976