Cleared Traditional

K052551 - DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE

K052551 is an FDA 510(k) clearance for DEVON STANDARD SYRINGE, manufactured by Devon Safety Products, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K052551 · Devon Safety Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
14d
Days
Class 2
Risk

K052551 is an FDA 510(k) clearance for the DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Devon Safety Products, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on September 30, 2005 after a review of 14 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 Devon Safety Products, Inc. devices

FDA 510(k) Submission Details - K052551

510(k) Number K052551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date September 30, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 414
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K052551.
MODIFICATION TO: VACLOK SYRINGE
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SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
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