FDA product code LKF: Cannula, Manipulator/Injector, Uterine
LKF is the FDA product code for cannula, manipulator/injector, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 87 510(k) submissions under LKF, 9 in the last five years, from 47 different applicants. The average 510(k) review took 194 days (median 154); 130 days on average over the last three years. FDA has posted 13 recalls for LKF devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Manipulator/Injector, Uterine |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LKF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 83 |
| 2018 | 4 | 268 |
| 2019 | 1 | 269 |
| 2022 | 4 | 85 |
| 2024 | 3 | 158 |
| 2025 | 2 | 102 |
Compare with all 510(k) review times · Search every LKF clearance
Top LKF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Femasys, Inc. | 7 | 2025-12-15 |
| Ackrad Laboratories | 6 | 2002-05-21 |
| Cook Incorporated | 5 | 2019-03-29 |
| CooperSurgical, Inc. | 4 | 2022-10-28 |
| Catheter Research, Inc. | 4 | 2013-01-31 |
42 more applicants have LKF clearances. See the full list in Caduvo.
Most recent LKF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253403 | Femasys, Inc. | FemVue® Controlled Saline-Air Device (FSA-300) | 2025-12-15 | 76 |
| K252260 | Li Medical Corporation , Ltd. | RELIEEV HSG Catheter (HSG7FA1) | 2025-11-26 | 128 |
| K242002 | Femasys, Inc. | FemVue MINI Saline-Air Device | 2024-11-22 | 136 |
| K240364 | Li Medical Corporation , Ltd. | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | 2024-10-16 | 253 |
| K241693 | Femasys, Inc. | FemChec Controlled Saline-Air Device (FCD-250) | 2024-09-06 | 86 |
Recalls for LKF devices
13 product recalls in 9 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 4 |
Frequently asked questions
What is FDA product code LKF?
LKF is the FDA product code for cannula, manipulator/injector, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is LKF?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKF?
Across 87 cleared submissions the average was 194 days from receipt to decision (median 154).
Which companies have the most LKF clearances?
Femasys, Inc. (7); Ackrad Laboratories (6); Cook Incorporated (5); CooperSurgical, Inc. (4); Catheter Research, Inc. (4).
Have LKF devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LKF
- Run a recall and safety report across every LKF manufacturer
- Watch product code LKF 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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