FDA product code LXC: Monitor, Pressure, Intracompartmental
LXC is the FDA product code for monitor, pressure, intracompartmental. It is a Unclassified device, reviewed by the Orthopedic panel. FDA has cleared 15 510(k) submissions under LXC, 4 in the last five years, from 8 different applicants. The average 510(k) review took 116 days (median 90); 189 days on average over the last three years. FDA has posted 2 recalls for LXC devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Pressure, Intracompartmental |
| Device class | Unclassified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 166 |
| 2021 | 1 | 58 |
| 2022 | 1 | 53 |
| 2023 | 1 | 143 |
| 2025 | 1 | 168 |
| 2026 | 1 | 210 |
Compare with all 510(k) review times · Search every LXC clearance
Top LXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| MY01, Inc. | 6 | 2026-01-16 |
| Twin Star Medical, Inc. | 3 | 2014-02-07 |
| Compremium AG | 1 | 2023-04-14 |
| Twin Star Medical | 1 | 2006-06-06 |
| Synthes (Usa) | 1 | 2003-07-08 |
3 more applicants have LXC clearances. See the full list in Caduvo.
Most recent LXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251900 | MY01, Inc. | MY01 Continuous Compartmental Pressure Monitor | 2026-01-16 | 210 |
| K242997 | MY01, Inc. | MY01 Continuous Compartmental Pressure Monitor | 2025-03-13 | 168 |
| K223509 | Compremium AG | Compremium Compartment Compressibility Monitoring System (CPM#1) | 2023-04-14 | 143 |
| K220952 | MY01, Inc. | MY01 Continuous Compartmental Pressure Monitor | 2022-05-24 | 53 |
| K210525 | MY01, Inc. | MY01 Continuous Compartmental Pressure Monitor | 2021-04-22 | 58 |
Recalls for LXC devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-06-28.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code LXC?
LXC is the FDA product code for monitor, pressure, intracompartmental. It is a Unclassified device, reviewed by the Orthopedic panel.
What device class is LXC?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXC?
Across 15 cleared submissions the average was 116 days from receipt to decision (median 90).
Which companies have the most LXC clearances?
MY01, Inc. (6); Twin Star Medical, Inc. (3); Compremium AG (1); Twin Star Medical (1); Synthes (Usa) (1).
Have LXC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-06-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LXC
- Run a recall and safety report across every LXC manufacturer
- Watch product code LXC 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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