Cleared Traditional

K860889 - SAMPLE MANIFOLD HOLDER

K860889 is an FDA 510(k) clearance for SAMPLE MANIFOLD HOLDER, manufactured by R. Bell. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K860889 · R. Bell · General Hospital
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Apr 1986
Decision
28d
Days
Class 2
Risk

K860889 is an FDA 510(k) clearance for the SAMPLE MANIFOLD HOLDER. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by R. Bell (Irvine, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 28 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 R. Bell devices

FDA 510(k) Submission Details - K860889

510(k) Number K860889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date April 07, 1986
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 60
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K860889.
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987
EXEL THREE-WAY STOPCOCK
K862492 · Exel Intl. · Sep 1986
CHURCHILL 3-WAY STOPCOCK SET
K854348 · Churchill Corp. · Nov 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984