Cleared Traditional

K010359 - INNOVO

K010359 is an FDA 510(k) clearance for INNOVO, manufactured by Novo Nordisk A/S. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K010359 · Novo Nordisk A/S · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
36d
Days
Class 2
Risk

K010359 is an FDA 510(k) clearance for the INNOVO. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Novo Nordisk A/S (Princeton, US). The FDA issued a Cleared decision on March 14, 2001 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Novo Nordisk A/S devices

FDA 510(k) Submission Details - K010359

510(k) Number K010359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2001
Decision Date March 14, 2001
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 474
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K010359.
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · Micromedics, Inc. · Oct 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc. · Sep 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · Sterling Medivations, Inc. · Dec 2000