Cleared Traditional

K853851 - FRESENIUS DISPOSABLE BLOOD LINES

K853851 is an FDA 510(k) clearance for FRESENIUS DISPOSABLE BLOOD LINES, manufactured by Seratronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K853851 · Seratronics, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
57d
Days
Class 2
Risk

K853851 is an FDA 510(k) clearance for the FRESENIUS DISPOSABLE BLOOD LINES. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Seratronics, Inc. (Concord, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 57 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.

View all Seratronics, Inc. devices

FDA 510(k) Submission Details - K853851

510(k) Number K853851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date November 12, 1985
Days to Decision 57 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
74d faster than avg
Panel avg: 131d · This submission: 57d
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 60
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K853851.
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · National Medical Care, Medical Products Div., Inc. · Sep 1988
KAWASUMI BLOOD TUBING LINE
K873516 · Kawasumi Laboratories Co., Ltd. · Oct 1987
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
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309 · Erika, Inc. · Jul 1985