FDA product code LNS: Lithotriptor, Extracorporeal Shock-Wave, Urological
LNS is the FDA product code for lithotriptor, extracorporeal shock-wave, urological. It is a Class II device, regulated under 21 CFR 876.5990 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 56 510(k) submissions under LNS, 5 in the last five years, from 32 different applicants. The average 510(k) review took 157 days (median 116); 171 days on average over the last three years. 13 PMA applications cite this product code. FDA has posted 1 recall for LNS devices.
Classification
| Field | Value |
|---|---|
| Device name | Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Device class | Class II |
| Regulation | 21 CFR 876.5990 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for LNS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 98 |
| 2020 | 1 | 134 |
| 2021 | 1 | 348 |
| 2023 | 2 | 325 |
| 2025 | 1 | 267 |
| 2026 | 2 | 75 |
Compare with all 510(k) review times · Search every LNS clearance
Top LNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Direx Systems Corp. | 7 | 2012-03-01 |
| Dornier Medtech America, Inc. | 5 | 2023-02-22 |
| KARL STORZ Endoscopy-America, Inc. | 5 | 2012-06-12 |
| Lite-Med, Inc. | 3 | 2023-01-19 |
| Dornier Medtech America | 3 | 2017-06-28 |
27 more applicants have LNS clearances. See the full list in Caduvo.
Most recent LNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261086 | Sonomotion, Inc. | Break Wave | 2026-04-29 | 28 |
| K252913 | Sonomotion, Inc. | Break Wave | 2026-01-12 | 122 |
| K242922 | Shenzhen Wikkon Precision Technologies Co., Ltd. | Extracorporeal Shock Wave Lithotripter (U200) | 2025-06-18 | 267 |
| K221903 | Dornier Medtech America, Inc. | Delta III Pro | 2023-02-22 | 237 |
| K213772 | Lite-Med, Inc. | LM-9300 Plus Lithotripter | 2023-01-19 | 413 |
Recalls for LNS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-24.
Frequently asked questions
What is FDA product code LNS?
LNS is the FDA product code for lithotriptor, extracorporeal shock-wave, urological. It is a Class II device, regulated under 21 CFR 876.5990 and reviewed by the Gastroenterology and Urology panel.
What device class is LNS?
Class II, regulation 21 CFR 876.5990. Typical premarket route: 510(k).
How long does a 510(k) take for product code LNS?
Across 56 cleared submissions the average was 157 days from receipt to decision (median 116).
Which companies have the most LNS clearances?
Direx Systems Corp. (7); Dornier Medtech America, Inc. (5); KARL STORZ Endoscopy-America, Inc. (5); Lite-Med, Inc. (3); Dornier Medtech America (3).
Have LNS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LNS
- Run a recall and safety report across every LNS manufacturer
- Watch product code LNS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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