Cleared Traditional

K903809 - PROTECTED NEEDLE WITH OR WITHOUT IV SET

K903809 is an FDA 510(k) clearance for PROTECTED NEEDLE WITH OR WITHOUT IV SET, manufactured by Kendall Mcgaw Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K903809 · Kendall Mcgaw Laboratories, Inc. · General Hospital
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Oct 1990
Decision
44d
Days
Class 2
Risk

K903809 is an FDA 510(k) clearance for the PROTECTED NEEDLE WITH OR WITHOUT IV SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Kendall Mcgaw Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on October 3, 1990 after a review of 44 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 Kendall Mcgaw Laboratories, Inc. devices

FDA 510(k) Submission Details - K903809

510(k) Number K903809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date October 03, 1990
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K903809.
B-D SAFETY-LOK(TM) I.V. NEEDLES
K911136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1991
PIGGY LOCK NEEDLE HOUSING
K910546 · Icu Medical, Inc. · Apr 1991
STERILE I.V. START KIT
K902810 · Orion Life Systems, Inc. · Nov 1990
IN-LINE VIAL CONNECTION SITE
K900909 · Baxter Healthcare Corp · May 1990
ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
K900187 · Advance Medical Designs, Inc. · May 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188 · Advance Medical Designs, Inc. · May 1990