FDA product code LQR: Dislodger, Stone, Biliary
LQR is the FDA product code for dislodger, stone, biliary. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 38 510(k) submissions under LQR, 5 in the last five years, from 25 different applicants. The average 510(k) review took 123 days (median 102); 147 days on average over the last three years. FDA has posted 11 recalls for LQR devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dislodger, Stone, Biliary |
| Device class | Class II |
| Regulation | 21 CFR 876.5010 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LQR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 142 |
| 2018 | 3 | 193 |
| 2019 | 1 | 22 |
| 2020 | 1 | 194 |
| 2021 | 1 | 195 |
| 2023 | 1 | 193 |
| 2024 | 2 | 152 |
| 2025 | 1 | 97 |
| 2026 | 1 | 193 |
Compare with all 510(k) review times · Search every LQR clearance
Top LQR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 4 | 2018-03-01 |
| Boston Scientific Corp | 4 | 2007-06-29 |
| Wilson-Cook Medical, Inc. | 3 | 2018-10-30 |
| Olympus Medical Systems Corp. | 2 | 2025-03-18 |
| Boston Scientific Corporation | 2 | 2021-05-26 |
20 more applicants have LQR clearances. See the full list in Caduvo.
Most recent LQR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253056 | Zhejiang Soudon Medical Technology Co., Ltd. | Disposable Stone Extraction Basket | 2026-04-03 | 193 |
| K243807 | Olympus Medical Systems Corp. | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | 2025-03-18 | 97 |
| K243471 | Micro-Tech (Nanjing) Co., Ltd. | Extraction Basket | 2024-12-16 | 38 |
| K240192 | Scivita Medical Technology Co., Ltd. | Single-use Extraction Baskets | 2024-10-15 | 265 |
| K230598 | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Stone Extraction Baskets | 2023-09-12 | 193 |
Recalls for LQR devices
11 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-03-05.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code LQR?
LQR is the FDA product code for dislodger, stone, biliary. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel.
What device class is LQR?
Class II, regulation 21 CFR 876.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQR?
Across 38 cleared submissions the average was 123 days from receipt to decision (median 102).
Which companies have the most LQR clearances?
Cook Incorporated (4); Boston Scientific Corp (4); Wilson-Cook Medical, Inc. (3); Olympus Medical Systems Corp. (2); Boston Scientific Corporation (2).
Have LQR devices been recalled?
Yes: 11 product recalls across 3 recall events; the most recent began 2026-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LQR
- Run a recall and safety report across every LQR manufacturer
- Watch product code LQR 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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