Cleared Traditional

K082454 - MICROMYST APPLICATOR

K082454 is the FDA 510(k) clearance for MICROMYST APPLICATOR by Covidien. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K082454 · Covidien · General Hospital
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Nov 2008
Decision
73d
Days
Class 2
Risk

K082454 is an FDA 510(k) clearance for the MICROMYST APPLICATOR, MODEL 20-5000. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Covidien (Waltham, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 73 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 Covidien devices

Submission Details

510(k) Number K082454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2008
Decision Date November 07, 2008
Days to Decision 73 days
Submission Type Traditional
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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 279
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K082454.
EPIDRUM
K093863 · Exmoor Plastics , Ltd. · May 2010
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BD FLU+ SYRINGE
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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
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007