Cleared Traditional

K061092 - BAXTER DUPLOSPRAY MIS APPLICATOR

K061092 is the FDA 510(k) clearance for BAXTER DUPLOSPRAY MIS APPLICATOR by Micromedics, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K061092 · Micromedics, Inc. · General Hospital
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Sep 2006
Decision
147d
Days
Class 2
Risk

K061092 is an FDA 510(k) clearance for the BAXTER DUPLOSPRAY MIS APPLICATOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 13, 2006 after a review of 147 days - within the typical 510(k) review window.

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: 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 Micromedics, Inc. devices

Submission Details

510(k) Number K061092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date September 13, 2006
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K061092.
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INJEKT SYRINGE
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ARTHREX ASPIRATE KIT
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MODIFICATION TO BONE GRAFT SYRINGE
K062173 · Wrightmedicaltechnologyinc · Aug 2006
MEDLINE SYRINGES, MULTIPLE
K061275 · Medline Industries, Inc. · Jul 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006