What are FDA-cleared vacuum erection devices available in the US as of 2025?

1. What the question means and the reporting limits

The user seeks a catalogue of VEDs that have formal FDA clearance in the U.S. as of 2025, which requires cross‑checking manufacturer claims against FDA 510(k)/premarket records; the available sources include an FDA 510(k) summary for Imagyn’s Irnpower System and multiple vendor/manufacturer statements that describe devices as “FDA‑cleared” or “FDA‑approved,” but those vendor pages do not always link directly to FDA docket numbers, so public reporting here cannot fully certify every marketing claim without consulting the FDA database directly ^{[1] [8] [4] [3] [2] [5] [6]}.

2. Devices documented in the reporting as FDA‑cleared or with FDA 510(k) material

Imagyn Medical Technologies’ Irnpower System appears in FDA premarket material in the reporting—a 510(k) summary is listed for the Imagyn Irnpower Vacuum Erection System ^[1]. Vendor and manufacturer sites cited in the reporting identify Pos‑T‑Vac products and the Pos‑T‑Vac Erect Vac Max as “FDA‑approved” or “FDA‑approved pumps” and list design features like safety valves consistent with FDA guidance ^{[2] [9]}. Augusta Medical’s SomaTherapy Manual and SomaTherapy Premium models are presented by a seller (menMD) as FDA‑approved devices available through its catalog ^[3]. ErecAid (Timm Medical/Osbon) and Vitality OTC Premium systems are advertised on vendor pages as FDA‑approved or FDA‑cleared in the materials provided ^{[10] [5]}. Vacurect’s manufacturer site claims FDA and CE clearance for the VACURECT™ device ^[4]. These are the specific product names and vendor claims recorded in the reporting ^{[1] [2] [3] [5] [4]}.

3. Marketing claims versus regulatory proof: a cautionary note

Multiple sources in the reporting repeat manufacturer or reseller language—“FDA‑approved,” “FDA‑cleared,” or “medical‑grade”—but marketing copy is not a substitute for the FDA’s 510(k) or PMN record; FDA guidance for external penile rigidity devices specifies required safety features such as quick‑release and vacuum limits, which appear in many product descriptions but require confirmation that the listed device’s 510(k) references those design controls ^{[6] [11]}. Clinical resources and consumer guidance (MedlinePlus, Mount Sinai) explicitly warn consumers to confirm FDA clearance and choose devices with vacuum limiters and quick‑release valves to reduce injury risk ^{[7] [11]}.

4. Clinical context, safety and how clinicians approach device selection

Medical centers and clinical guides describe VEDs as an effective, non‑pharmacologic option for erectile dysfunction and penile rehabilitation, recommending devices with safety features (pop‑off valves, constriction rings used for limited time) and urging consultation with a clinician because non‑medical consumer pumps may lack necessary safety limits ^{[11] [7]}. Professional sellers and specialty shops emphasize that models they stock are “clinically tested” or “FDA‑approved,” which is useful but should be corroborated by regulators’ records to avoid buying lower‑quality consumer pumps that lack safety features ^{[3] [8]}.

5. How to verify and final takeaway

The reporting identifies named VEDs promoted as FDA‑cleared—Imagyn Irnpower, Pos‑T‑Vac products, SomaTherapy models, Vacurect, ErecAid/Vitality OTC among them—but also shows that many of these assertions are on vendor/manufacturer pages rather than directly linked to FDA docket pages, so the definitive confirmation step is to search the FDA 510(k)/PMN database for each model or consult a prescribing clinician or supplier that can provide the 510(k) number ^{[1] [2] [3] [4] [5] [6]}. Reporting and regulatory guidance together support that several established brands claim clearance and that safety‑oriented features are commonly marketed, but public reporting here cannot independently certify every clearance claim without direct FDA record checks ^{[1] [6] [7]}.