Cleared Traditional

K896990 - PHARMULATOR

K896990 is an FDA 510(k) clearance for PHARMULATOR, 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 100-day FDA review.

K896990 · Acacia, Inc. · General Hospital
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Mar 1990
Decision
100d
Days
Class 2
Risk

K896990 is an FDA 510(k) clearance for the PHARMULATOR. 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 March 23, 1990 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Acacia, Inc. devices

FDA 510(k) Submission Details - K896990

510(k) Number K896990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date March 23, 1990
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 K896990.
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
LUER LOCK TRANSFER PIN
K901063 · Acacia, Inc. · Jul 1990
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · Abbott Laboratories · Jun 1990
AUTOMIX 3+3 COMPOUNDER
K894827 · Baxter Healthcare Corp · Oct 1989
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · Baxter Healthcare Corp · Nov 1988
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · Churchill Corp. · May 1986