Cleared Traditional

K811917 - I.V. ADMIN. SETS FOR THE AMP MARK IV PMP

K811917 is an FDA 510(k) clearance for I.V. ADMIN. SETS FOR THE AMP MARK IV PMP, manufactured by American Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K811917 · American Medical Products, Inc. · General Hospital
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Jul 1981
Decision
21d
Days
Class 2
Risk

K811917 is an FDA 510(k) clearance for the I.V. ADMIN. SETS FOR THE AMP MARK IV PMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 American Medical Products, Inc. devices

FDA 510(k) Submission Details - K811917

510(k) Number K811917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1981
Decision Date July 23, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 597
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K811917.
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
VOLUMETRIC INFUSION PUMP
K812021 · American Edwards Laboratories · Jul 1981
IMED ACCUSET CASSETTE
K812035 · Imed Corp. · Jul 1981
IVAC 700 SYRINGE INFUSION PUMP
K811884 · Y · Jul 1981
AMP MARK IV INFUSION PUMP
K811918 · American Medical Products, Inc. · Jul 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · Biosearch Medical Products, Inc. · Jul 1981