Cleared Traditional

K841827 - ENTEROPORT NUTRITION PUMP

K841827 is an FDA 510(k) clearance for ENTEROPORT NUTRITION PUMP, manufactured by Diatek, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K841827 · Diatek, Inc. · General Hospital
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Jul 1984
Decision
85d
Days
Class 2
Risk

K841827 is an FDA 510(k) clearance for the ENTEROPORT NUTRITION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Diatek, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 85 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.

FDA 510(k) Submission Details - K841827

510(k) Number K841827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1984
Decision Date July 27, 1984
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 831
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841827.
RADIONUCLIDE INFUSION SYSTEM
K842568 · Squibb Diagnostics · Oct 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · American Edwards Laboratories · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
MTP E.V. INFUSION PUMP
K842263 · Ziehm International, Inc. · Jul 1984
SR- MODEL 230
K842289 · Hirata Sangyo Co. USA, Inc. · Jul 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · Y · Jul 1984
K841827 · ENTEROPORT NUTRITION PUMP
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