Cleared Traditional

K850506 - CORRECT FLO INTRAVASCULAR ADMINISTRATIO...

K850506 is the FDA 510(k) clearance for CORRECT FLO INTRAVASCULAR ADMINISTRATIO... by Biomedical Dynamics, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K850506 · Biomedical Dynamics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
52d
Days
Class 2
Risk

K850506 is an FDA 510(k) clearance for the CORRECT FLO INTRAVASCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Biomedical Dynamics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 52 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 Biomedical Dynamics, Inc. devices

Submission Details

510(k) Number K850506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date April 01, 1985
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 453
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K850506.
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · Y · Jun 1985
CORRECT FLO
K851299 · Norton Performance Plastics Corp. · May 1985
IVAC DRUG ADMINISTRATION DEVICE
K844843 · Y · Apr 1985
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · Travenol Laboratories, S.A. · Mar 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · Critikon Company, LLC · Mar 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · Y · Jan 1985