Cleared Traditional

KSEA CALCUSPLIT (K992114) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992114 · Karl Storz Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
57d
Days
Class 2
Risk

K992114 is an FDA 510(k) clearance for the KSEA CALCUSPLIT. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on August 18, 1999 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 876.4480 - 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 devices

Submission Details

510(k) Number K992114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1999
Decision Date August 18, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FFK Lithotriptor, Electro-hydraulic

All 9
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K992114.
URO-TOUCH 9 French Probe
K202813 · Northgate Technologies, Inc. · Jun 2021
Swiss LithoClast Trilogy
K191124 · E.M.S Electro Medical Systems S.A · May 2019
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · Boston Scientific Corp · Jul 2000
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989