Cleared Traditional

K960486 - KSEA MODEL 383320 20 ANGIOMAT

K960486 is an FDA 510(k) clearance for KSEA MODEL 383320 20 ANGIOMAT, manufactured by Karl Storz Endoscopy. The device is a Class 2 General Hospital device with product code DQI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K960486 · Karl Storz Endoscopy · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
266d
Days
Class 2
Risk

K960486 is an FDA 510(k) clearance for the KSEA MODEL 383320 20 ANGIOMAT. Classified as Withdrawal/infusion Pump (product code DQI), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1800 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Karl Storz Endoscopy devices

FDA 510(k) Submission Details - K960486

510(k) Number K960486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1996
Decision Date October 25, 1996
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQI Device Classification - Class 2, Special Controls

Product Code DQI Withdrawal/infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1800
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 General Hospital devices follow this clearance model.

Regulatory Peers - DQI Withdrawal/infusion Pump

Devices cleared under the same product code (DQI) and FDA review panel - the closest regulatory comparables to K960486.
SURGIPUMP
K935763 · W.O.M. World of Medicine GmbH · Apr 1994
USCI SUPER 9 PTCA GUIDING CATHETER
K922541 · C.R. Bard, Inc. · Dec 1992
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)
K905189 · Baxter Healthcare Corp · Jan 1991
ANGIOSCOPY PUMP
K895074 · Baxter Healthcare Corp · Jan 1990
OLYMPUS ANGIOSCOPY PUMP
K871422 · Olympus Corp. · Aug 1987