Cleared Traditional

K821148 - ETHOX FOOD PUMP STAND W/POLE CLAMP

K821148 is an FDA 510(k) clearance for ETHOX FOOD PUMP STAND W/POLE CLAMP, manufactured by Ethox Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K821148 · Ethox Corp. · General Hospital
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May 1982
Decision
12d
Days
Class 2
Risk

K821148 is an FDA 510(k) clearance for the ETHOX FOOD PUMP STAND W/POLE CLAMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ethox Corp. (7600 Ridge Blvd Brooklun, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 12 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 Ethox Corp. devices

FDA 510(k) Submission Details - K821148

510(k) Number K821148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1982
Decision Date May 05, 1982
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
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 586
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K821148.
DELIVERY TUBE SET #2226
K822761 · Delta Medical Industries · Sep 1982
FLEXIFLO-II
K821661 · Abbott Laboratories · Jun 1982
MODEL AS6M INFUSION PUMP
K821069 · Baxter Healthcare Corp · Jun 1982
IVAC 630 & VOLUMETRIC INFUSION PUMP
K821047 · Y · May 1982
AS 70 VOLUMETRIC INFUSION PUMP
K820946 · Narco Scientific · Apr 1982
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K820860 · Travenol Laboratories, S.A. · Apr 1982