Cleared Traditional

INJECTION PORT II --- FOR INTERMITTENT INJECTION (K896291) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896291 · The Medi-Dose Group · General Hospital
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Dec 1989
Decision
31d
Days
Class 2
Risk

K896291 is an FDA 510(k) clearance for the INJECTION PORT II --- FOR INTERMITTENT INJECTION. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by The Medi-Dose Group (Feasterville, US). The FDA issued a Cleared decision on December 1, 1989 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 The Medi-Dose Group devices

Submission Details

510(k) Number K896291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1989
Decision Date December 01, 1989
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
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.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K896291.
IN-LINE VIAL CONNECTION SITE
K900909 · Baxter Healthcare Corp · May 1990
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K896161 · 3M Company · Jan 1990
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · Baxter Healthcare Corp · Dec 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716 · Baxter Healthcare Corp · Sep 1989
MODIFIED MATERIAL USED IN INFUSION T
K893909 · Quinton, Inc. · Aug 1989
SURFLO(R) WINGED INFUSION SET
K891063 · Terumo Medical Corp. · Jun 1989