Cleared Traditional

K852616 - MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE

K852616 is an FDA 510(k) clearance for MIRAGE INTRAVENOUS INFUSION SET OLOVSON..., manufactured by Medical Hospital Equipment. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K852616 · Medical Hospital Equipment · General Hospital
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Apr 1986
Decision
299d
Days
Class 2
Risk

K852616 is an FDA 510(k) clearance for the MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medical Hospital Equipment (Chula Vista, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 299 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 Medical Hospital Equipment devices

FDA 510(k) Submission Details - K852616

510(k) Number K852616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date April 07, 1986
Days to Decision 299 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
170d slower than avg
Panel avg: 129d · This submission: 299d
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 853
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K852616.
CHURCHILL INJECTION SITE
K861430 · Churchill Corp. · May 1986
CHURCHILL FEMALE LUER LOCK CAP
K861439 · Churchill Corp. · May 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157 · Quest Medical, Inc. · Apr 1986
CLINISET INFUSION SET
K860322 · Zimmar Consulting , Ltd. · Apr 1986
SOLUTION ADMINISTRATION SET
K860541 · Travenol Laboratories, S.A. · Mar 1986
SOLUTION ADMINISTRATION SETS
K860272 · Travenol Laboratories, S.A. · Mar 1986