Cleared Traditional

K843168 - ENTERAL FEEDING PUMP 14-800 SERIES

K843168 is the FDA 510(k) clearance for ENTERAL FEEDING PUMP 14-800 SERIES by Biosearch Medical Products, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K843168 · Biosearch Medical Products, Inc. · General Hospital
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Oct 1984
Decision
72d
Days
Class 2
Risk

K843168 is an FDA 510(k) clearance for the ENTERAL FEEDING PUMP 14-800 SERIES. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 72 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K843168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date October 24, 1984
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 435
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K843168.
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984
INTERMEDICS SYRINGE PUMP 710-02
K843548 · Intermedics, Inc. · Oct 1984
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · American Edwards Laboratories · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · Y · Jul 1984