FDA product code KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube
KLA is the FDA product code for monitor, esophageal motility, anorectal motility, and tube. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 31 510(k) submissions under KLA, 3 in the last five years, from 22 different applicants. The average 510(k) review took 214 days (median 172); 140 days on average over the last three years. FDA has posted 1 recall for KLA devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Device class | Class II |
| Regulation | 21 CFR 876.1725 |
| 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 KLA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 258 |
| 2018 | 1 | 50 |
| 2024 | 2 | 121 |
| 2025 | 1 | 160 |
Compare with all 510(k) review times · Search every KLA clearance
Top KLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oakfield Instruments, Ltd. | 3 | 1997-08-06 |
| Thd Spa | 2 | 2018-03-08 |
| Medspira, LLC | 2 | 2015-07-07 |
| Mediplus , Ltd. | 2 | 2004-01-16 |
| Sandhill Scientific, Inc. | 2 | 1996-06-06 |
17 more applicants have KLA clearances. See the full list in Caduvo.
Most recent KLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242666 | Gi Bionics, LLC | Fecobionics Anorectal System | 2025-02-12 | 160 |
| K242304 | Neuraxis, Inc. | RED | 2024-12-06 | 123 |
| K234107 | Laborie Medical Technologies, Corp. | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | 2024-04-23 | 119 |
| K180135 | Thd Spa | THD Anopress with THD SensyProbe | 2018-03-08 | 50 |
| K161785 | Thd Spa | THD ANOPRESS | 2017-03-14 | 258 |
Recalls for KLA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-04-06.
Frequently asked questions
What is FDA product code KLA?
KLA is the FDA product code for monitor, esophageal motility, anorectal motility, and tube. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel.
What device class is KLA?
Class II, regulation 21 CFR 876.1725. Typical premarket route: 510(k).
How long does a 510(k) take for product code KLA?
Across 31 cleared submissions the average was 214 days from receipt to decision (median 172).
Which companies have the most KLA clearances?
Oakfield Instruments, Ltd. (3); Thd Spa (2); Medspira, LLC (2); Mediplus , Ltd. (2); Sandhill Scientific, Inc. (2).
Have KLA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KLA
- Run a recall and safety report across every KLA manufacturer
- Watch product code KLA 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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