Cleared Traditional

K895882 - JMS DIALYZER PRIMING SET

K895882 is the FDA 510(k) clearance for JMS DIALYZER PRIMING SET by Jms Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K895882 · Jms Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
127d
Days
Class 2
Risk

K895882 is an FDA 510(k) clearance for the JMS DIALYZER PRIMING SET. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on February 9, 1990 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jms Co., Ltd. devices

Submission Details

510(k) Number K895882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date February 09, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 130d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 116
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K895882.
INTRODUCER NEEDLES
K910641 · Akcess Medical Products, Inc. · Apr 1991
Y ADAPTOR
K910321 · Akcess Medical Products, Inc. · Apr 1991
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · National Medical Care, Medical Products Div., Inc. · Feb 1990
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · Baxter Healthcare Corp · Dec 1989
NATIONAL MEDICAL CARE VENOUS LINE 03-9548
K894637 · National Medical Care, Medical Products Div., Inc. · Sep 1989
FAST FORMALERT
K853555 · Organon Teknika Corp. · Jun 1986