Cleared Traditional

K870722 - LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE

K870722 is an FDA 510(k) clearance for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL..., manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with 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.

FDA 510(k) Submission Details - K870722

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
456d slower than avg
Panel avg: 131d · This submission: 587d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K870722.
HAEMOTRONIC BLOOD LINE SET
K896407 · Healthcare Suppliers, Inc. · Apr 1990
BIOPRIME TM KIT
K892932 · Hospal · Jun 1989
BLOOD TUBING SET
K884243 · Mediflex Intl. · Dec 1988
KAWASUMI BLOOD TUBING LINE
K873516 · Kawasumi Laboratories Co., Ltd. · Oct 1987
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
K873455 · Dravon Medical, Inc. · Sep 1987
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
K864784 · Cd Medical, Inc. · Jan 1987
K870722 · LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
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