Cleared Traditional

K010888 - SIDEPORT PINCH CLAMP DEVICE

K010888 is an FDA 510(k) clearance for SIDEPORT PINCH CLAMP DEVICE, manufactured by Medivice Systems, Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K010888 · Medivice Systems, Ltd. · General Hospital
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Jun 2001
Decision
96d
Days
Class 2
Risk

K010888 is an FDA 510(k) clearance for the SIDEPORT PINCH CLAMP DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medivice Systems, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on June 27, 2001 after a review of 96 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.

FDA 510(k) Submission Details - K010888

510(k) Number K010888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date June 27, 2001
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
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 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K010888.
SIMPLICITY EURO QD INFUSION SET
K012330 · Sterling Medivations, Inc. · Aug 2001
PVC FREE INTRAVASCULAR ADMINISTRATION SET
K011216 · Biometrix , Ltd. · Jul 2001
CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
K003254 · Mission Medicl Devices · Jul 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187 · Sterling Medivations, Inc. · Jun 2001
INTERLINK THREADED LOCK CANNULA
K011858 · Bd · Jun 2001
NAC PLUS NEEDLELESS ACCESS CONNECTOR
K011193 · Porex Medical Products · Jun 2001
K010888 · SIDEPORT PINCH CLAMP DEVICE
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