Cleared Abbreviated

K070856 - ICU MEDICAL SINGLE-USE SYRINGE

K070856 is the FDA 510(k) clearance for ICU MEDICAL SINGLE-USE SYRINGE by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Abbreviated 510(k) pathway after a 191-day FDA review.

K070856 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
191d
Days
Class 2
Risk

K070856 is an FDA 510(k) clearance for the ICU MEDICAL SINGLE-USE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 191 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Icu Medical, Inc. devices

Submission Details

510(k) Number K070856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date October 05, 2007
Days to Decision 191 days
Submission Type Abbreviated
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
62d slower than avg
Panel avg: 129d · This submission: 191d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 280
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070856.
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007