Cleared Traditional

K870722 - LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL...

K870722 is the FDA 510(k) clearance for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL... by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 587-day FDA review.

K870722 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Sep 1988
Decision
587d
Days
Class 2
Risk

K870722 is an FDA 510(k) clearance for the LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on September 14, 1988 after a review of 587 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K870722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1987
Decision Date September 14, 1988
Days to Decision 587 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
457d slower than avg
Panel avg: 130d · This submission: 587d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 41
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K870722.
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · Terumo Medical Corp. · Aug 1991
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
K903021 · National Medical Care, Medical Products Div., Inc. · Aug 1990
ARTERIAL/VENOUS BLOODLINES
K901688 · National Medical Care, Medical Products Div., Inc. · Aug 1990
ERIKA ARTERIAL LINE 03-9625-9
K860740 · National Medical Care, Medical Products Div., Inc. · Mar 1986
ASA BLOOD TUBING LINES
K854271 · Organon Teknika Corp. · Nov 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962 · National Medical Care, Medical Products Div., Inc. · Oct 1985