FDA product code LHD: Device, Fertility Diagnostic, Proceptive
LHD is the FDA product code for device, fertility diagnostic, proceptive. It is a Unclassified device, reviewed by the Obstetrics and Gynecology panel. FDA has cleared 24 510(k) submissions under LHD, from 21 different applicants. The average 510(k) review took 209 days (median 130).
Classification
| Field | Value |
|---|---|
| Device name | Device, Fertility Diagnostic, Proceptive |
| Device class | Unclassified |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LHD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 363 |
Compare with all 510(k) review times · Search every LHD clearance
Top LHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioself, Inc. | 3 | 1992-10-14 |
| Nishitomo Co., Inc. | 2 | 2003-04-08 |
| Ava AG | 1 | 2021-01-19 |
| Fertility Focus, Ltd. | 1 | 2013-08-06 |
| Cambridge Temperature Concepts , Ltd. | 1 | 2011-12-20 |
16 more applicants have LHD clearances. See the full list in Caduvo.
Most recent LHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200163 | Ava AG | Ava Fertility Tracker | 2021-01-19 | 363 |
| K122337 | Fertility Focus, Ltd. | OVUSENSE | 2013-08-06 | 369 |
| K102499 | Cambridge Temperature Concepts , Ltd. | DUOFERTILITY | 2011-12-20 | 476 |
| K050094 | Lady Comp USA | LADY COMP USA | 2006-04-20 | 461 |
| K030961 | Microlife Corp. | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | 2003-09-12 | 169 |
Recalls for LHD devices
openFDA lists no recalls for product code LHD.
Frequently asked questions
What is FDA product code LHD?
LHD is the FDA product code for device, fertility diagnostic, proceptive. It is a Unclassified device, reviewed by the Obstetrics and Gynecology panel.
What device class is LHD?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LHD?
Across 24 cleared submissions the average was 209 days from receipt to decision (median 130).
Which companies have the most LHD clearances?
Bioself, Inc. (3); Nishitomo Co., Inc. (2); Ava AG (1); Fertility Focus, Ltd. (1); Cambridge Temperature Concepts , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHD
- Run a recall and safety report across every LHD manufacturer
- Watch product code LHD 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times