Cleared Traditional

K830818 - ASAHI BLOOD/PLASMA PUMP #ABP-01A &

K830818 is an FDA 510(k) clearance for ASAHI BLOOD/PLASMA PUMP #ABP-01A &, manufactured by Parker Hannifin Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830818 · Parker Hannifin Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
28d
Days
Class 2
Risk

K830818 is an FDA 510(k) clearance for the ASAHI BLOOD/PLASMA PUMP #ABP-01A &. Classified as Pump, Blood, Extra-luminal (product code FIR), Class II - Special Controls.

Submitted by Parker Hannifin Corp. (Walker, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K830818

510(k) Number K830818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1983
Decision Date April 12, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIR Device Classification - Class 2, Special Controls

Product Code FIR Pump, Blood, Extra-luminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIR Pump, Blood, Extra-luminal

Devices cleared under the same product code (FIR) and FDA review panel - the closest regulatory comparables to K830818.
ATI PLASMA PUMP (PP-04)
K961137 · Apheresis Technologies, Inc. · Jun 1996
INFUSION PUMP
K831953 · Cryosan, Inc. · Jul 1983
SPS-SINGLE PATIENT SYSTEM
K821139 · Extracorporeal Medical Specialities, Inc. · May 1982
BLOOD PUMP-MODE S10K
K780410 · 3M Health Care, Sarns · May 1978
RS-7800 MINIPUMP
K771705 · Renal Systems, Inc. · Oct 1977
HEPARIN PUMP
K761050 · Dws, Inc. · Dec 1976
K830818 · ASAHI BLOOD/PLASMA PUMP #ABP-01A &
Download PDF Parker Hannifin Corp.