Cleared Traditional

K810757 - I.V. ADMINISTRATION SET

K810757 is the FDA 510(k) clearance for I.V. ADMINISTRATION SET by American Mcgaw. It is a Class 2 Gastroenterology & Urology device (product code FDA) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K810757 · American Mcgaw · Gastroenterology & Urology device
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Apr 1981
Decision
19d
Days
Class 2
Risk

K810757 is an FDA 510(k) clearance for the I.V. ADMINISTRATION SET. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by American Mcgaw (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 American Mcgaw devices

Submission Details

510(k) Number K810757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date April 08, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 130d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDA Enteroscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Gastroenterology & Urology devices follow this clearance model.