Cleared Traditional

K822571 - SYRINGE PUMP

K822571 is an FDA 510(k) clearance for SYRINGE PUMP, 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 45-day FDA review.

K822571 · Hirata Sangyo Co. USA, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1982
Decision
45d
Days
Class 2
Risk

K822571 is an FDA 510(k) clearance for the SYRINGE PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hirata Sangyo Co. USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982 after a review of 45 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 - K822571

510(k) Number K822571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date October 08, 1982
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 K822571.
BETATRON II
K823204 · Cardiac Pacemakers, Inc. · Nov 1982
COMPUTER INTERFACE MODULE CIM
K823035 · Y · Nov 1982
HARVARD APPARATUS SINGLE SPEED SYRINGE
K822989 · C.R. Bard, Inc. · Nov 1982
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