Cleared Traditional

K050998 - CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063

K050998 is an FDA 510(k) clearance for CONFLUENT SURGICAL MICROMYST APPLICATOR..., manufactured by Confluent Surgical,Inc. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050998 · Confluent Surgical,Inc · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
56d
Days
Class 2
Risk

K050998 is an FDA 510(k) clearance for the CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Confluent Surgical,Inc (Waltham, US). The FDA issued a Cleared decision on June 15, 2005 after a review of 56 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 Confluent Surgical,Inc devices

FDA 510(k) Submission Details - K050998

510(k) Number K050998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date June 15, 2005
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 378
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K050998.
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · Nipro Medical Corp. · Aug 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
STRYKER DISCMONITOR
K050753 · Stryker Instruments · May 2005
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
K033589 · Micromedics, Inc. · Oct 2004