Cleared Traditional

K801004 - FLOW MED 160

K801004 is an FDA 510(k) clearance for FLOW MED 160, manufactured by D.R.O. Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K801004 · D.R.O. Medical, Inc. · General Hospital
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May 1980
Decision
7d
Days
Class 2
Risk

K801004 is an FDA 510(k) clearance for the FLOW MED 160. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by D.R.O. Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 7 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 - K801004

510(k) Number K801004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1980
Decision Date May 02, 1980
Days to Decision 7 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
122d faster than avg
Panel avg: 129d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 855
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K801004.
MCGRAW I.V. ADMINISTRATION SET
K801540 · American Hospital Supply Corp. · Aug 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
K801613 · Y · Aug 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · Travenol Laboratories, S.A. · May 1980
Y-TYPE INFUSION SET (2 LEAD)
K800358 · Haemonetics Corp. · Apr 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403 · American Hospital Supply Corp. · Apr 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980