Cleared Traditional

K860703 - U - STAR (MICRO-STAR)

K860703 is the FDA 510(k) clearance for U - STAR (MICRO-STAR) by Corning Costar Corp.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K860703 · Corning Costar Corp. · General Hospital
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May 1986
Decision
69d
Days
Class 2
Risk

K860703 is an FDA 510(k) clearance for the U - STAR (MICRO-STAR). Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Corning Costar Corp. (Cambridge, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 69 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 Corning Costar Corp. devices

Submission Details

510(k) Number K860703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1986
Decision Date May 06, 1986
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K860703.
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MODIFIED SLIDING RECONSTITUTION DEVICE
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MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · Churchill Corp. · May 1986
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · Travenol Laboratories, S.A. · Nov 1985
VIAL VENT FILTER
K852467 · Baxter Healthcare Corp · Oct 1985