Cleared Traditional

BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE (K930217) - FDA 510(k) Clearance

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

K930217 · Baxter Healthcare Corp · General Hospital
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Feb 1994
Decision
409d
Days
Class 2
Risk

K930217 is an FDA 510(k) clearance for the BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K930217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1993
Decision Date February 28, 1994
Days to Decision 409 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
280d slower than avg
Panel avg: 129d · This submission: 409d
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 180
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K930217.
MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
K943578 · Sherwood Medical Co. · Aug 1994
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · Baxter Healthcare Corp · Aug 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · Baxter Healthcare Corp · Aug 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · Sherwood Medical Co. · Feb 1994
MONOJECT VERTICAL ENTRY SHARPS CONTAINER
K934404 · Sherwood Medical Co. · Feb 1994
AUTO SUTURE SHARPS CONTAINER
K934088 · United States Surgical, A Division of Tyco Healthc · Feb 1994