Which vacuum erection devices appear in FDA 510(k) records and how to search the FDA database for cleared VEDs?
Executive summary
Vacuum erection devices (VEDs) appear in FDA records as Class II external penile rigidity devices with manufacturers and specific models documented in 510(k) summaries and complementary registries; named products that show up in the provided reporting include Vacurect and models sold by Augusta Medical (SomaTherapy), while many commercial claims (e.g., “first rechargeable” pumps) exist in marketing materials but are not independently confirmed in the supplied FDA records [1] [2] [3]. The FDA’s publicly accessible 510(k) listings and individual PDF summaries are the authoritative places to verify clearance and device-specific details [4] [5].
1. Which specific VEDs appear in FDA-facing records and clinical registries
The Vacurect device is explicitly documented in government-adjacent registries and manufacturer material: Vacurect appears in the AccessGUDID device entry (National Library of Medicine/GUDID) describing the Vacurect vacuum erection device and its catalog data [1], and its marketing pages claim design features calibrated to FDA pressure limits [6]; Augusta Medical’s SomaTherapy models are identified repeatedly in provider-focused outlets and vendor materials as FDA-cleared medical-grade VEDs (SomaTherapy Manual and Premium are cited by menMD and Augusta Medical) and are presented as devices available through clinical channels [2] [7]. An example FDA 510(k) summary PDF in the supplied material (k020969) corresponds to a vacuum constriction/erection device 510(k) submission, illustrating that individual device summaries can be pulled from FDA document repositories [5]. The supplied reporting does not include a comprehensive, up-to-date list of every cleared VED; it names these exemplars but acknowledges the broader commercial ecosystem where many vendors make marketing claims without linked 510(k) evidence in the provided sources [3] [8] [7].
2. How the FDA frames and regulates VEDs in 510(k) and guidance documents
VEDs are regulated as Class II external penile rigidity devices with special controls that address design features such as vacuum-limiting or quick-release mechanisms, constriction rings, labeling warnings, and surface design to reduce injury risk—features the FDA explicitly recommends in its guidance for this device class [9]. The agency treats many VEDs through the 510(k) pathway when manufacturers demonstrate substantial equivalence to predicate devices; FDA 510(k) listings are therefore the primary signal that a marketed product has been reviewed for equivalence and associated controls [4]. Clinical and hospital sites caution that consumer-grade pumps sold without medical-grade claims may lack these safety features and present greater risk [10] [11].
3. How to search the FDA database for cleared VEDs (step-by-step approach)
Start at the FDA’s 510(k) database and the “Recently-Approved Devices”/Clearances listings to find entries for “vacuum erection device,” “vacuum constriction device,” or the regulatory device name “external penile rigidity device”; the FDA site posts 510(k) summaries and PDF submissions (an example 510(k) PDF is included in the reporting) that show predicate claims and intended use [4] [5]. Cross-reference any candidate model name with the GUDID/AccessGUDID registry to retrieve device identifiers and packaging details (as done for Vacurect) and then consult the manufacturer’s 510(k) number or FDA summary PDF for clearance language and special controls [1] [5]. When a vendor claims “FDA” status in marketing, verify by locating the actual 510(k) number or clearance notice on the FDA site rather than relying on promotional copy [3] [8].
4. What to watch for in marketing claims and real-world safety signals
Marketing statements that call devices “FDA-approved” or “first FDA rechargeable” should be investigated against 510(k) records because class II devices are typically “cleared” via 510(k) rather than “approved” via PMA, and manufacturers are often “deemed substantially equivalent” rather than “FDA approved” [7] [4]. Clinical guidance and hospital resources stress safety features—pop‑off/pressure‑limit valves and quick-release mechanisms—to reduce injury; purchases without those features or without a verifiable 510(k) clearance risk patient harm, particularly for men on anticoagulants or with penile comorbidities [10] [9] [11].
5. Limitations in the available reporting and next verification steps
The supplied material names representative cleared devices and shows where to locate 510(k) PDFs and registry entries, but it does not provide an exhaustive, timestamped list of every VED currently cleared by the FDA; a thorough verification requires searching the FDA 510(k) database and GUDID directly for model names and 510(k) numbers, then reading the linked FDA summaries for indications, predicate devices, and special controls [5] [1] [4]. Where vendor claims appear (e.g., EDP‑MAXRc, Vitality OTC), they should be treated as marketing assertions until matched to an FDA 510(k) record or GUDID entry in the federal databases cited above [3] [8].