Cleared Traditional

K844917 - TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE

K844917 is an FDA 510(k) clearance for TURN NEEDLE INTRAVENOUS CANNUL, manufactured by Turn Needle Intl., Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K844917 · Turn Needle Intl., Inc. · General Hospital
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Feb 1985
Decision
50d
Days
Class 2
Risk

K844917 is an FDA 510(k) clearance for the TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Turn Needle Intl., Inc. (Miami Beach, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 50 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 Turn Needle Intl., Inc. devices

FDA 510(k) Submission Details - K844917

510(k) Number K844917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1984
Decision Date February 07, 1985
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 855
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K844917.
IVAC DRUG ADMINISTRATION DEVICE
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CRITIKON I.V. ADMINISTRAION SET
K850507 · Critikon Company, LLC · Mar 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · Y · Jan 1985
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984