Cleared Traditional

K900353 - SHIELDED PIGGYBACK IV NEEDLE

K900353 is an FDA 510(k) clearance for SHIELDED PIGGYBACK IV NEEDLE, manufactured by Pascall Saringia Medical Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K900353 · Pascall Saringia Medical Corp. · General Hospital
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Jun 1990
Decision
148d
Days
Class 2
Risk

K900353 is an FDA 510(k) clearance for the SHIELDED PIGGYBACK IV NEEDLE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pascall Saringia Medical Corp. (Cocoa Beach, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Pascall Saringia Medical Corp. devices

FDA 510(k) Submission Details - K900353

510(k) Number K900353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1990
Decision Date June 22, 1990
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 836
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K900353.
KAWASUMI SMALL VEIN INFUSION SET
K896896 · Kawasumi Laboratories Co., Ltd. · Sep 1990
WINGED INFUSION SET
K902166 · Therex Corp. · Aug 1990
EXEL HUBER INFUSION SET
K895770 · Exel Intl. · Jul 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