FDA product code HRX: Arthroscope
HRX is the FDA product code for arthroscope. It is a Class II device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel. FDA has cleared 683 510(k) submissions under HRX, 27 in the last five years, from 283 different applicants. The average 510(k) review took 132 days (median 89); 165 days on average over the last three years. FDA has posted 126 recalls for HRX devices, 4 initiated in the last five years.
Definition
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Arthroscope |
| Device class | Class II |
| Regulation | 21 CFR 888.1100 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HRX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 109 |
| 2018 | 12 | 143 |
| 2019 | 12 | 63 |
| 2020 | 7 | 166 |
| 2021 | 7 | 128 |
| 2022 | 3 | 151 |
| 2023 | 4 | 238 |
| 2024 | 6 | 106 |
| 2025 | 9 | 168 |
| 2026 | 5 | 220 |
Compare with all 510(k) review times · Search every HRX clearance
Top HRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 28 | 2010-10-18 |
| Arthrex, Inc. | 27 | 2025-05-16 |
| Acufex Microsurgical, Inc. | 26 | 1996-06-21 |
| Linvatec Corp. | 19 | 2006-05-11 |
| Smith & Nephew, Inc. | 18 | 2019-09-04 |
278 more applicants have HRX clearances. See the full list in Caduvo.
Most recent HRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260203 | Beijing Fule Science & Technology Development Co., Ltd. | Fule Vertebroplasty Balloon Catheter | 2026-08-28 | 217 |
| K254103 | Karl Storz SE & CO. KG | HOPKINS Telescopes for Arthroscopy | 2026-08-26 | 250 |
| K252790 | Clarus Medical, LLC | Digital ClarusScope System and Digital NeuroPEN System | 2026-05-26 | 266 |
| K253523 | Spinal Simplicity | Freedom DS Decompression System | 2026-04-16 | 154 |
| K252546 | Allevion Medical, LLC | VantageTM Lumbar Decompression Kit | 2026-03-12 | 212 |
Recalls for HRX devices
126 product recalls in 52 recall events; 4 initiated in the last five years and 8 still open. Most recent: 2025-02-11.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 16 |
| 2020 | 4 |
| 2021 | 4 |
| 2024 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HRX?
HRX is the FDA product code for arthroscope. It is a Class II device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel.
What device class is HRX?
Class II, regulation 21 CFR 888.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRX?
Across 683 cleared submissions the average was 132 days from receipt to decision (median 89).
Which companies have the most HRX clearances?
KARL STORZ Endoscopy-America, Inc. (28); Arthrex, Inc. (27); Acufex Microsurgical, Inc. (26); Linvatec Corp. (19); Smith & Nephew, Inc. (18).
Have HRX devices been recalled?
Yes: 126 product recalls across 52 recall events; the most recent began 2025-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HRX
- Run a recall and safety report across every HRX manufacturer
- Watch product code HRX 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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