Cleared Traditional

K842289 - SR- MODEL 230

K842289 is an FDA 510(k) clearance for SR- MODEL 230, manufactured by Hirata Sangyo Co. USA, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K842289 · Hirata Sangyo Co. USA, Inc. · General Hospital
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Jul 1984
Decision
47d
Days
Class 2
Risk

K842289 is an FDA 510(k) clearance for the SR- MODEL 230. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hirata Sangyo Co. USA, Inc. (Walker, US). The FDA issued a Cleared decision on July 25, 1984 after a review of 47 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 Hirata Sangyo Co. USA, Inc. devices

FDA 510(k) Submission Details - K842289

510(k) Number K842289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1984
Decision Date July 25, 1984
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 609
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K842289.
ENTERAL FEEDING PUMP 14-800 SERIES
K843168 · Biosearch Medical Products, 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
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K841922 · American Edwards Laboratories · Jul 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984