Cleared Traditional

ENTEROPORT NUTRITION PUMP (K841827) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Diatek, Inc. devices

Submission Details

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.

Device Classification

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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841827.
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983