Cleared Traditional

K963583 - MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE

K963583 is an FDA 510(k) clearance for MIXJECT DISPENSING PIN/WITH DETACHABLE ..., manufactured by Medimop Medical Projects, Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K963583 · Medimop Medical Projects, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
31d
Days
Class 2
Risk

K963583 is an FDA 510(k) clearance for the MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDE.... Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (Raanana, IL). The FDA issued a Cleared decision on October 7, 1996 after a review of 31 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 Medimop Medical Projects, Ltd. devices

FDA 510(k) Submission Details - K963583

510(k) Number K963583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1996
Decision Date October 07, 1996
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
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 95
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K963583.
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · Faulding Medical Device Co. · May 1997
CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
K964989 · Critical Device Corp. · Apr 1997
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · B.Braun Medical, Inc. · Mar 1997
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
FORMULATION PREPARATION DEVICE
K955398 · B.Braun Medical, Inc. · Apr 1996
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · B. Braun of America, Inc. · Sep 1994