Which vacuum erection devices (VEDs) received FDA clearance for erectile dysfunction in 2025?
Executive summary
No authoritative FDA record in the provided reporting identifies any vacuum erection device (VED) that received new FDA clearance specifically in 2025; available materials instead show longstanding clearances, vendor claims of FDA clearance for marketed products, and a historical FDA clearance dating to 1982 for the device class (Vacurect 510(k) documents and vendor pages are present, but none are explicit FDA clearance announcements dated 2025) [1] [2] [3] [4] [5]. The safest conclusion from these sources is that no verifiable, FDA-published clearance for a VED in 2025 can be identified in the supplied reporting.
1. What the question really asks and why the record matters
The user seeks a concrete list of VEDs that obtained FDA clearance in calendar year 2025, which is a narrow administrative fact that should be verifiable in FDA databases or formal 510(k)/PMA documents; the supplied material includes vendor claims and a historic 510(k) but lacks any FDA-issued clearance notices dated 2025, so an authoritative, source-backed answer naming devices cleared in 2025 cannot be produced from these sources [1] [2] [3] [4].
2. What the official and peer-reviewed reporting shows about VED regulatory history
A comprehensive review in Sexual Medicine Reviews notes that the vacuum erection device class was cleared by the FDA in 1982 and has been an accepted treatment modality since then, establishing a long regulatory and clinical history rather than a flurry of new 2025 clearances [2]. The Vacurect 510(k) summary available in the FDA archive demonstrates a prior 510(k) pathway for a named VED (Vacurect), illustrating the typical regulatory route for these devices rather than documenting a 2025 approval [1].
3. What vendor and clinical-education pages claim (and their limitations)
Commercial sites selling VEDs make explicit claims that their products are “FDA-cleared” or “FDA-approved” — for example, menMD asserts its VEDs are “FDA-cleared” and clinically tested (pages dated 2025 in the supplied snippets), ErecAid promotes the “EDP‑MAXRc” as the “First FDA Rechargeable Automatic Medical Grade” pump, and vendor listings for Pos‑T‑Vac pumps describe them as “FDA-approved” — but these are manufacturer or reseller statements and the supplied reporting does not include matching FDA 510(k) or approval documents dated 2025 to corroborate those specific claims [3] [4] [5] [6].
4. Clinical context and safety notes that matter when interpreting “FDA-cleared” claims
Authoritative clinical and patient-education sources underscore that FDA-cleared medical-grade VEDs have safety features such as pop-off valves and that non‑cleared “penis developers” sold online can pose risk because they lack FDA clearance and testing; these references show why an accurate, FDA-documented list matters for patient safety, even as vendor marketing can blur the picture [7] [8] [9].
5. Conclusion: evidence-based answer and reporting gap
Based on the documents and excerpts provided, there is no direct evidence in this reporting that any specific vacuum erection device received a new FDA clearance in 2025; available material documents historical clearances (class clearance in 1982 and individual 510(k) records such as Vacurect’s file) and vendor claims of FDA clearance for marketed products, but not a verifiable list of devices cleared during calendar year 2025 in FDA records contained here [2] [1] [3] [4] [5]. To conclusively answer the original narrow question would require consulting the FDA’s 510(k) and De Novo databases or specific FDA press releases for 2025 entries, which are not included among the supplied sources.