FDA product code LKY: Device, External Penile Rigidity
LKY is the FDA product code for device, external penile rigidity. It is a Class II device, regulated under 21 CFR 876.5020 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 87 510(k) submissions under LKY, from 48 different applicants. The average 510(k) review took 131 days (median 100).
Definition
Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, External Penile Rigidity |
| Device class | Class II |
| Regulation | 21 CFR 876.5020 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LKY clearance
Top LKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pos-T-Vac, Inc. | 11 | 2002-04-04 |
| Nanma Mfg Co., Ltd. | 9 | 2004-08-25 |
| Ercons, Inc. | 6 | 1999-02-24 |
| Vts, Inc. | 5 | 2001-11-09 |
| Walling Medical Equipment Co. | 4 | 1998-05-06 |
43 more applicants have LKY clearances. See the full list in Caduvo.
Most recent LKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041573 | Nanma Mfg Co., Ltd. | NANMA VACUUM PUMP PROXZEK MODEL 2M9498S | 2004-08-25 | 72 |
| K032776 | Vacurect Manufacturing (Pty) , Ltd. | VACURECT VACUUM CONSTRICTION DEVICE | 2003-10-03 | 25 |
| K030119 | Nanma Mfg Co., Ltd. | NANMA ADJUSTABLE CONSTRICTION RING | 2003-08-06 | 205 |
| K030913 | Nanma Mfg Co., Ltd. | NANMA VACUUM PUMP | 2003-06-03 | 71 |
| K013113 | Nanma Mfg Co., Ltd. | MODIFICATION TO NANMA VACUUM PUMP | 2002-12-20 | 458 |
Recalls for LKY devices
openFDA lists no recalls for product code LKY.
Frequently asked questions
What is FDA product code LKY?
LKY is the FDA product code for device, external penile rigidity. It is a Class II device, regulated under 21 CFR 876.5020 and reviewed by the Gastroenterology and Urology panel.
What device class is LKY?
Class II, regulation 21 CFR 876.5020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LKY?
Across 87 cleared submissions the average was 131 days from receipt to decision (median 100).
Which companies have the most LKY clearances?
Pos-T-Vac, Inc. (11); Nanma Mfg Co., Ltd. (9); Ercons, Inc. (6); Vts, Inc. (5); Walling Medical Equipment Co. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code LKY
- Run a recall and safety report across every LKY manufacturer
- Watch product code LKY 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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