Cleared Traditional

K061092 - BAXTER DUPLOSPRAY MIS APPLICATOR

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

K061092 · Micromedics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K061092

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
Combination Product No
PCCP Authorized No
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.

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 483
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K061092.
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006
INJEKT SYRINGE
K063280 · B.Braun Medical, Inc. · Nov 2006
ARTHREX ASPIRATE KIT
K062365 · Arthrex, 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