Cleared Traditional

FLIPTIP SAFETY NEEDLE (K933601) - FDA 510(k) Clearance

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

K933601 · Syntuition, Inc. · General Hospital
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Jun 1994
Decision
332d
Days
Class 2
Risk

K933601 is an FDA 510(k) clearance for the FLIPTIP SAFETY NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Syntuition, Inc. (Etna, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 332 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Syntuition, Inc. devices

Submission Details

510(k) Number K933601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date June 24, 1994
Days to Decision 332 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 129d · This submission: 332d
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 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K933601.
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
BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K930217 · Baxter Healthcare Corp · Feb 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · Sherwood Medical Co. · Feb 1994
MONOJECT VERTICAL ENTRY SHARPS CONTAINER
K934404 · Sherwood Medical Co. · Feb 1994