Cleared Traditional

K870324 - #014460-120 3-WAY & #014461-120 4-WAY S...

K870324 is an FDA 510(k) clearance for #014460-120 3-WAY & #014461-120 4-WAY S..., manufactured by Clinical Connections, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K870324 · Clinical Connections, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
44d
Days
Class 2
Risk

K870324 is an FDA 510(k) clearance for the #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Clinical Connections, Inc. (Orrville, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Clinical Connections, Inc. devices

FDA 510(k) Submission Details - K870324

510(k) Number K870324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date March 13, 1987
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FMG Stopcock, I.v. Set

All 40
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K870324.
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987
CHURCHILL 3-WAY STOPCOCK SET
K854348 · Churchill Corp. · Nov 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985