Which VED models are FDA-cleared for erectile dysfunction in 2025?
This fact-check may be outdated. Consider refreshing it to get the most current information.
Executive summary
No single, consolidated public list in the supplied sources names which vacuum erection device (VED) models are FDA‑cleared in 2025; the FDA maintains searchable 510(k) clearance records that include 2025 entries (Cleared 510(k) Submissions page) but the provided FDA pages do not list specific VED model names in the search results we were given [1]. Clinical reviews and specialty guidance in 2025 make VEDs a recommended and longstanding option for ED and penile rehabilitation, but model‑level clearance details are not present in these sources [2] [3].
1. Why your question matters — regulatory detail drives clinical and purchasing choices
Clinicians, hospitals and patients rely on FDA 510(k) clearances to know a device’s marketed indication, predicate device and the regulatory basis for use; the FDA’s cleared 510(k) submissions listing for 2025 is the authoritative starting point for checking model‑level clearances, but the source excerpt we have (Cleared 510(k) Submissions with Supporting Documents) simply describes the list rather than naming VED models [1]. That means model names and their indications must be confirmed by searching FDA databases or manufacturers’ 510(k) summaries beyond the supplied snippets [1].
2. What the peer‑review literature and societies say about VEDs in 2025
Professional reviews in 2025 reaffirm VEDs as recommended treatment options for erectile dysfunction and for post‑radical prostatectomy penile rehabilitation; Sexual Medicine Reviews states clinicians should offer VED alone or combined with other therapies for intercourse [2]. Systematic reviews and meta‑analyses published in 2025 report VEDs remain an evidence‑based, non‑pharmacologic therapy for many etiologies of ED [3]. Those clinical endorsements increase demand and explain why purchasers often ask which specific, FDA‑cleared models meet procurement or insurance requirements [2] [3].
3. What the FDA material in our packet actually provides — process, not a shopping list
The supplied FDA page description notes a list of cleared 510(k) submissions for 2025 with available supporting documents, reflecting information as of each clearance date, but the excerpt does not show device‑level entries or VED model names in the material you provided [1]. In practice, locating cleared models requires using the FDA’s searchable 510(k) database or downloading the clearance summaries referenced on that page; those device‑specific records are the only FDA citations that definitively show which models were cleared and for what indications [1].
4. Manufacturer claims vs. authoritative clearance records
Manufacturer and vendor pages (example: menMD) commonly state “our VEDs are FDA‑cleared” and explain device function and recommended use, but such marketing language is not a substitute for the FDA 510(k) document that names the cleared model and its exact indication language [4] [5]. Because manufacturers can market multiple configurations and may update product names, verifying by cross‑referencing the company’s stated 510(k) number to the FDA database is required to avoid misinformation [4] [1].
5. Practical next steps to get an authoritative model list
To compile a definitive list of VED models that were FDA‑cleared in 2025, consult the FDA’s 510(k) searchable database and the “Cleared 510(k) Submissions with Supporting Documents — 2025” page to retrieve device listings and summaries; then match manufacturer model names to 510(k) numbers and indications [1]. The supplied sources do not include a pre‑assembled, model‑level list, so further queries of the FDA database and manufacturer 510(k) summaries are necessary [1] [4].
6. Conflicts, limitations and why exact model names often change
Device marketing names, bundled accessories, and incremental product updates can lead to differing public product pages and FDA 510(k) records; our available reporting does not enumerate such model changes or specific 2025 VED clearances [1]. Clinical literature and reviews confirm VED therapy’s role in ED care but do not function as regulatory verification of particular cleared models [2] [3].
If you want, I will (A) search the FDA 510(k) database and the “Cleared 510(k) Submissions with Supporting Documents — 2025” page for VED entries and return a list of model names and 510(k) numbers, or (B) cross‑check specific manufacturer model names you provide against the FDA records. Available sources do not mention specific cleared VED model names in the material you supplied [1].