Cleared Traditional

K880006 - STA-SET I.V. FLOW REGULATOR

K880006 is an FDA 510(k) clearance for STA-SET I.V. FLOW REGULATOR, manufactured by Controlled Flow , Ltd.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K880006 · Controlled Flow , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1988
Decision
80d
Days
Class 2
Risk

K880006 is an FDA 510(k) clearance for the STA-SET I.V. FLOW REGULATOR. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Controlled Flow , Ltd. (Stafford, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Controlled Flow , Ltd. devices

FDA 510(k) Submission Details - K880006

510(k) Number K880006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date March 24, 1988
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - LDR Controller, Infusion, Intravascular, Electronic

All 33
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K880006.
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
K894487 · Y · Sep 1989
LIFECARE 75 CONTROLLER
K893487 · Abbott Laboratories · Jul 1989
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
K884307 · Y · Nov 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
K874481 · Y · Mar 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · Technicon Instruments Corp. · Mar 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491 · Y · Feb 1988