Cleared Traditional

K760631 - FILTER SET 1288

K760631 is the FDA 510(k) clearance for FILTER SET 1288 by Sorensen Research. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K760631 · Sorensen Research · Gastroenterology & Urology device

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Oct 1976

Decision

32d

Days

Class 2

Risk

K760631 is an FDA 510(k) clearance for the FILTER SET 1288. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on October 15, 1976 after a review of 32 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 Sorensen Research devices

Submission Details

510(k) Number	K760631 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 13, 1976
Decision Date	October 15, 1976
Days to Decision	32 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

98d faster than avg

Panel avg: 130d · This submission: 32d

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 80

Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K760631.

FILTER SET PMF 2448

K760628 · Sorensen Research · Oct 1976

FILTER SET PMF 100

K760629 · Sorensen Research · Oct 1976

FILTER SET PMF 200

K760630 · Sorensen Research · Oct 1976

FILTER SET PMF 2024

K760632 · Sorensen Research · Oct 1976

FILTER SET PMF 1028

K760633 · Sorensen Research · Oct 1976

FILTER SET, PMF 1448

K760637 · Sorensen Research · Oct 1976

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K760631

Sorensen Research

Mchenry, IL · US

Regulatory profile

69 submissions 69 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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