Cleared Traditional

K873444 - ENTECH ENTERAL PUMP AND SET

K873444 is an FDA 510(k) clearance for ENTECH ENTERAL PUMP AND SET, manufactured by Entech, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K873444 · Entech, Inc. · General Hospital
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Nov 1987
Decision
67d
Days
Class 2
Risk

K873444 is an FDA 510(k) clearance for the ENTECH ENTERAL PUMP AND SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Entech, Inc. (Lebanon, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 67 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 Entech, Inc. devices

FDA 510(k) Submission Details - K873444

510(k) Number K873444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1987
Decision Date November 02, 1987
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 460
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K873444.
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · Y · Dec 1987
VALLEYLAB MODEL IV7200 INFUSION PUMP
K873161 · Valleylab, Inc. · Nov 1987
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
K872764 · Y · Nov 1987
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K870656 · Imed Corp. · Oct 1987
NUTRIPUMP
K872741 · I M, Inc. · Oct 1987
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · Imed Corp. · Oct 1987