Cleared Traditional

K974198 - TAKY-SPIKE PLUS

K974198 is an FDA 510(k) clearance for TAKY-SPIKE PLUS, manufactured by Clinico. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K974198 · Clinico · General Hospital
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Dec 1997
Decision
42d
Days
Class 2
Risk

K974198 is an FDA 510(k) clearance for the TAKY-SPIKE PLUS. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Clinico (Bad Hersfeld, DE). The FDA issued a Cleared decision on December 22, 1997 after a review of 42 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 Clinico devices

FDA 510(k) Submission Details - K974198

510(k) Number K974198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date December 22, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K974198.
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