Cleared Traditional

K905664 - VIAL ACCESS CANNULA

K905664 is the FDA 510(k) clearance for VIAL ACCESS CANNULA by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K905664 · Baxter Healthcare Corp · General Hospital
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Mar 1991
Decision
87d
Days
Class 2
Risk

K905664 is an FDA 510(k) clearance for the VIAL ACCESS CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K905664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date March 15, 1991
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 245
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K905664.
INTRAOSSEOUS ACCESS NEEDLE
K915409 · Cook, Inc. · Mar 1992
MX927 BLOOD TRANSFER DEVICE
K913498 · Medex, Inc. · Nov 1991
MEGA MYELOGRAM KIT
K913141 · Megadyne Medical Products, Inc. · Oct 1991
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988
VIGGO VASCUPORT NEEDLE
K881758 · Ohmeda Medical · Jun 1988