Cleared Traditional

K901151 - I.V. ADMINISTRATION SET CONNECTING DEVICE

K901151 is an FDA 510(k) clearance for I.V. ADMINISTRATION SET CONNECTING DEVICE, manufactured by Dmd, Div. of Casta Pacific Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K901151 · Dmd, Div. of Casta Pacific Co. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1990
Decision
112d
Days
Class 2
Risk

K901151 is an FDA 510(k) clearance for the I.V. ADMINISTRATION SET CONNECTING DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Dmd, Div. of Casta Pacific Co. (Nevada City, US). The FDA issued a Cleared decision on July 2, 1990 after a review of 112 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 Dmd, Div. of Casta Pacific Co. devices

FDA 510(k) Submission Details - K901151

510(k) Number K901151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date July 02, 1990
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 K901151.
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