Cleared Traditional

K881666 - HR(TM) INTRAVASCULAR CATHETER

K881666 is the FDA 510(k) clearance for HR(TM) INTRAVASCULAR CATHETER by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K881666 · Icu Medical, Inc. · General Hospital
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May 1988
Decision
18d
Days
Class 2
Risk

K881666 is an FDA 510(k) clearance for the HR(TM) INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icu Medical, Inc. devices

Submission Details

510(k) Number K881666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1988
Decision Date May 06, 1988
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K881666.
VASCULON 2 INTRAVENOUS CANNULA
K883415 · Ohmeda Medical · Oct 1988
VIGGO INSUFLON
K881767 · Ohmeda Medical · Aug 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988
J&J SCALP VEIN INFUSION SETS
K875177 · Critikon Company, LLC · Jan 1988
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
CHURCHILL-CATH
K872585 · Churchill Corp. · Oct 1987