Cleared Traditional

K911230 - RS-1000

K911230 is an FDA 510(k) clearance for RS-1000, manufactured by Cp Medical. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 812-day FDA review.

K911230 · Cp Medical · Gastroenterology & Urology device
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Jun 1993
Decision
812d
Days
Class 2
Risk

K911230 is an FDA 510(k) clearance for the RS-1000. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Cp Medical (Huntington Beach, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 812 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 - K911230

510(k) Number K911230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1991
Decision Date June 09, 1993
Days to Decision 812 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
681d slower than avg
Panel avg: 131d · This submission: 812d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 181
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K911230.
CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
K925522 · C.G.H. Medical, Inc. · Sep 1994
CD HOME DIALYSERVICE HEMODIALYSIS TRAY
K925654 · Cd Medical, Inc. · Mar 1994
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994
DIGI -FLOW
K920671 · D and D Technology, Inc. · Jan 1993
HEMO-BAND
K920614 · Innovations IN Access, Inc. · Jul 1992
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · C.R. Bard, Inc. · Mar 1992
K911230 · RS-1000
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