Cleared Traditional

K974431 - CHEMO-SPIKE II RECONSTITUTION DEVICE

K974431 is an FDA 510(k) clearance for CHEMO-SPIKE II RECONSTITUTION DEVICE, manufactured by Medi-Dose, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K974431 · Medi-Dose, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
45d
Days
Class 2
Risk

K974431 is an FDA 510(k) clearance for the CHEMO-SPIKE II RECONSTITUTION DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medi-Dose, Inc. (Warminster, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 45 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 Medi-Dose, Inc. devices

FDA 510(k) Submission Details - K974431

510(k) Number K974431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date January 08, 1998
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 110
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K974431.
CHEMO MINI SPIKE PLUS
K983794 · B. Braun of America, Inc. · Mar 1999
IV DECANTER-FLEXIBLE
K980587 · Inrad · Apr 1998
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
K980381 · Carmel Pharma Ab. · Mar 1998
TAKY-SPIKE PLUS
K974198 · Clinico · Dec 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997