Cleared Traditional

FLOW MED 311 (K820165) - FDA 510(k) Clearance

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

K820165 · D.R.O. Medical, Inc. · General Hospital
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Feb 1982
Decision
12d
Days
Class 2
Risk

K820165 is an FDA 510(k) clearance for the FLOW MED 311. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by D.R.O. Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1982 after a review of 12 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 D.R.O. Medical, Inc. devices

Submission Details

510(k) Number K820165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1982
Decision Date February 01, 1982
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K820165.
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · Cordis Corp. · Feb 1979
STOPCOCK
K780596 · Abco Dealers, Inc. · Apr 1978