Cleared Traditional

K950970 - INFUSION SET

K950970 is an FDA 510(k) clearance for INFUSION SET, manufactured by Surgiplast , Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K950970 · Surgiplast , Ltd. · General Hospital
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Dec 1995
Decision
291d
Days
Class 2
Risk

K950970 is an FDA 510(k) clearance for the INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Surgiplast , Ltd. (Ahmedabad 382 445, IN). The FDA issued a Cleared decision on December 18, 1995 after a review of 291 days - an extended review 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: 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 Surgiplast , Ltd. devices

FDA 510(k) Submission Details - K950970

510(k) Number K950970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1995
Decision Date December 18, 1995
Days to Decision 291 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
162d slower than avg
Panel avg: 129d · This submission: 291d
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 820
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K950970.
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
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EXTENSION SET WITH CHECK VALVE
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K954870 · Sims Deltec, Inc. · Dec 1995
ICU EXTENSION KIT
K954813 · Icu Medical, Inc. · Nov 1995
LOW PROFILE SAFSITE Y-SITE
K954123 · B.Braun Medical, Inc. · Nov 1995