Cleared Traditional

K820165 - FLOW MED 311

K820165 is an FDA 510(k) clearance for FLOW MED 311, manufactured by D.R.O. Medical, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K820165 · D.R.O. Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K820165

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.

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 K820165.
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
ARTERIOGRAM TRAY
K812927 · American Pharmaseal Div. Ahsc · Nov 1981
STOPCOCK 2-WAY, 3-WAY & 4-WAY
K802258 · Stanco Medical, Inc. · Sep 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980