Cleared Traditional

K934591 - CLAVE VIAL ACCESS SPIKE

K934591 is an FDA 510(k) clearance for CLAVE VIAL ACCESS SPIKE, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K934591 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
145d
Days
Class 2
Risk

K934591 is an FDA 510(k) clearance for the CLAVE VIAL ACCESS SPIKE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 1994 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Icu Medical, Inc. devices

FDA 510(k) Submission Details - K934591

510(k) Number K934591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date February 16, 1994
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K934591.
BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K930217 · Baxter Healthcare Corp · Feb 1994
SHARPSAFE, CAT. NO. 4126
K935776 · Smiths Industries Medical Systems, Inc. · Feb 1994
SHARPSAFE, CAT. NO. 4125
K935777 · Smiths Industries Medical Systems, Inc. · Feb 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · Sherwood Medical Co. · Feb 1994
VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
K935514 · Kawasumi Laboratories Co., Ltd. · Feb 1994
MONOJECT VERTICAL ENTRY SHARPS CONTAINER
K934404 · Sherwood Medical Co. · Feb 1994