Cleared Traditional

K213772 - LM-9300 Plus Lithotripter (FDA 510(k) Clearance)

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

K213772 · Lite-Med, Inc. · Gastroenterology & Urology device
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Jan 2023
Decision
413d
Days
Class 2
Risk

K213772 is an FDA 510(k) clearance for the LM-9300 Plus Lithotripter. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Lite-Med, Inc. (Taipei, TW). The FDA issued a Cleared decision on January 19, 2023 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - 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.

View all Lite-Med, Inc. devices

Submission Details

510(k) Number K213772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2021
Decision Date January 19, 2023
Days to Decision 413 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 130d · This submission: 413d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
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 - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 55
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K213772.
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K201074 · Dornier Medtech America, Inc. · Sep 2020