Cleared Traditional

K061492 - MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE

K061492 is an FDA 510(k) clearance for MONOJECT MAGELLAN INSULIN AND TUBERCULI..., manufactured by Tyco Healthcare. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K061492 · Tyco Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
64d
Days
Class 2
Risk

K061492 is an FDA 510(k) clearance for the MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on August 3, 2006 after a review of 64 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 Tyco Healthcare devices

FDA 510(k) Submission Details - K061492

510(k) Number K061492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date August 03, 2006
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 481
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K061492.
ARTHREX ASPIRATE KIT
K062365 · Arthrex, Inc. · Sep 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092 · Micromedics, Inc. · Sep 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · Wrightmedicaltechnologyinc · Aug 2006
MEDLINE SYRINGES, MULTIPLE
K061275 · Medline Industries, Inc. · Jul 2006
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · Amsino International, Inc. · Jun 2006
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · Terumo Europe N.V. · Apr 2006