Cleared Traditional

K823056 - THE INGLEFIELD MAGIC RING

K823056 is an FDA 510(k) clearance for THE INGLEFIELD MAGIC RING, manufactured by The Inglefield Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K823056 · The Inglefield Co. · General Hospital
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Nov 1982
Decision
16d
Days
Class 2
Risk

K823056 is an FDA 510(k) clearance for the THE INGLEFIELD MAGIC RING. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by The Inglefield Co. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1982 after a review of 16 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 The Inglefield Co. devices

FDA 510(k) Submission Details - K823056

510(k) Number K823056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date November 03, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 545
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K823056.
DIRECTOR
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