Cleared Traditional

K901063 - LUER LOCK TRANSFER PIN

K901063 is an FDA 510(k) clearance for LUER LOCK TRANSFER PIN, 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 121-day FDA review.

K901063 · Acacia, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
121d
Days
Class 2
Risk

K901063 is an FDA 510(k) clearance for the LUER LOCK TRANSFER PIN. 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 July 6, 1990 after a review of 121 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 - K901063

510(k) Number K901063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date July 06, 1990
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 K901063.
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · Abbott Laboratories · Jun 1990
PHARMULATOR
K896990 · Acacia, Inc. · Mar 1990
AUTOMIX 3+3 COMPOUNDER
K894827 · Baxter Healthcare Corp · Oct 1989