Cleared Traditional

K832009 - MODEL #27224P CONTINUOUS FLOW PUMP

K832009 is an FDA 510(k) clearance for MODEL #27224P CONTINUOUS FLOW PUMP, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K832009 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Jul 1983
Decision
25d
Days
Class 2
Risk

K832009 is an FDA 510(k) clearance for the MODEL #27224P CONTINUOUS FLOW PUMP. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K832009

510(k) Number K832009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date July 18, 1983
Days to Decision 25 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
106d faster than avg
Panel avg: 131d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 81
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K832009.
RAPID ENDOSCOPIC LAVAGE SYSTEM
K862058 · Endovations · Aug 1986
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER
K844550 · Hobbs Medical, Inc. · Jan 1985
ASPIRATION & IRRIGATION CATHETER
K833331 · Microvasive · Nov 1983
LAVAGING CATHETERS
K822061 · American Endoscopy, Inc. · Jul 1982
PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT
K810506 · Propper Mfg. Co., Inc. · Apr 1981