Cleared Traditional

K971004 - MEDCORP FLOW I.V. REGULATOR EXTENSION SET

K971004 is an FDA 510(k) clearance for MEDCORP FLOW I.V. REGULATOR EXTENSION SET, manufactured by Medcorp Intl.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K971004 · Medcorp Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
197d
Days
Class 2
Risk

K971004 is an FDA 510(k) clearance for the MEDCORP FLOW I.V. REGULATOR EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medcorp Intl. (Laguna Hills, US). The FDA issued a Cleared decision on October 2, 1997 after a review of 197 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 Medcorp Intl. devices

FDA 510(k) Submission Details - K971004

510(k) Number K971004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1997
Decision Date October 02, 1997
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
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 645
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K971004.
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
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EXEL I.V. ADMINISTRATION SET
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POSITIVE PRESSURE CONNECTOR
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AMSINO I.V. ADMINISTRATION SET
K973107 · Amsino Intl., Inc. · Oct 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · Icu Medical, Inc. · Oct 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957 · Vlv Associates, Inc. · Sep 1997