Cleared Traditional

K883718 - MERIT HI-FLEX(TM)

K883718 is an FDA 510(k) clearance for MERIT HI-FLEX(TM), manufactured by Merit Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K883718 · Merit Medical Systems, Inc. · General Hospital
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Jan 1989
Decision
152d
Days
Class 2
Risk

K883718 is an FDA 510(k) clearance for the MERIT HI-FLEX(TM). Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 152 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K883718

510(k) Number K883718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date January 30, 1989
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
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 - FPK Tubing, Fluid Delivery

All 29
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K883718.
LIFESHIELD EXTENSION SET
K912103 · Abbott Laboratories · Dec 1991
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · 3M Company · May 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
K884156 · Sechrist Industries, Inc. · Nov 1988
IV EXTENSION SET
K875186 · Marquette Medical, Inc. · Feb 1988
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987