Cleared Traditional

K823827 - AMP 80/2 OUTFLOW MONITOR MODIFICATION

K823827 is an FDA 510(k) clearance for AMP 80/2 OUTFLOW MONITOR MODIFICATION, manufactured by American Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K823827 · American Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1983
Decision
87d
Days
Class 2
Risk

K823827 is an FDA 510(k) clearance for the AMP 80/2 OUTFLOW MONITOR MODIFICATION. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Medical Products, Inc. devices

FDA 510(k) Submission Details - K823827

510(k) Number K823827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1982
Decision Date March 17, 1983
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K823827.
AMPERCIDE DISINFECTANT ACCESSORY TO -
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