Cleared Traditional

K853212 - FLOW EASE(PLASTIC VENTED NEEDLE)

K853212 is an FDA 510(k) clearance for FLOW EASE(PLASTIC VENTED NEEDLE), manufactured by Acacia, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K853212 · Acacia, Inc. · General Hospital
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Sep 1985
Decision
50d
Days
Class 2
Risk

K853212 is an FDA 510(k) clearance for the FLOW EASE(PLASTIC VENTED NEEDLE). Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Acacia, Inc. (Loma Linda, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 50 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 Acacia, Inc. devices

FDA 510(k) Submission Details - K853212

510(k) Number K853212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1985
Decision Date September 19, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K853212.
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
TRANSFER DEVICE
K853188 · Advance Medical Designs, Inc. · Aug 1985
TANDEM SETS I.V.
K850757 · Acacia, Inc. · Apr 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · Travenol Laboratories, S.A. · Jan 1985