Cleared Traditional

K050753 - STRYKER DISCMONITOR

K050753 is the FDA 510(k) clearance for STRYKER DISCMONITOR by Stryker Instruments. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050753 · Stryker Instruments · General Hospital
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Optimized for regulatory review, auditing and printing
May 2005
Decision
56d
Days
Class 2
Risk

K050753 is an FDA 510(k) clearance for the STRYKER DISCMONITOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 18, 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 Stryker Instruments devices

Submission Details

510(k) Number K050753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2005
Decision Date May 18, 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
Combination Product No
PCCP Authorized No
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.

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K050753.
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
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SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
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K033721 · Vascular Solutions, Inc. · Feb 2004