Which vacuum erection devices have FDA 510(k) clearances and what do their 510(k) summaries say?
Executive summary
A small set of commercially marketed vacuum erection devices (VEDs) hold FDA 510(k)-era clearances or are registered in federal device databases, but public documentation varies: Imagyn Medical’s Irnpower/Vacurec family has an accessible 510(k) summary (PDF), while several widely sold brands (Vacurect, Pos‑T‑Vac and others) appear in FDA/GUDID entries or make claims of FDA clearance without readily available 510(k) summaries online [1] [2] [3] [4]. The FDA’s Class II guidance describes the specific safety features and labeling expectations that govern those clearances—most notably quick‑release valves/pop‑off pressure limits and warnings about use in blood‑thinning conditions [5] [6].
1. Which devices show explicit 510(k) documentation?
The clearest, directly sourced 510(k) summary in the reporting is for Imagyn Medical Technologies’ Irnpower System (also described as the Vacurec/Vacurect family in marketing), for which a 510(k) PDF is posted in FDA’s database [1]. That document is the only explicit 510(k) summary file surfaced among the provided sources; it serves as a concrete example of the type of premarket notification the FDA uses for VEDs [1].
2. Which marketed VEDs claim FDA clearance but lack posted summaries in the provided reporting?
Several manufacturers and retailers explicitly market devices as “FDA‑approved/cleared” or list GUDID registrations—Vacurect is listed in AccessGUDID with a device entry and product contents, indicating an FDA device registration record [2], and Pos‑T‑Vac appears in vendor materials as an “FDA‑approved” pump line [3]. Commercial sites and resellers (Vacurect, Pos‑T‑Vac, Vitality Medical, menMD, Augusta Medical, etc.) repeatedly state FDA clearance or approval in marketing copy, but the reporting does not include their 510(k) summaries for direct inspection [4] [3] [7] [8] [9] [10].
3. What do typical 510(k) summaries for VEDs say (design, safety, intended use)?
FDA guidance and clinical sources set consistent expectations that appear in 510(k) material: VEDs consist of a cylinder and hand or motorized pump that applies negative pressure to induce erection; safety features like a quick‑release mechanism or automatic vacuum limit are standard recommendations to prevent excessive pressure and injury; constriction rings are described as maintaining erections temporarily; and labeling must include warnings for people with sickle cell disease, anticoagulant use, or history of prolonged erections [5] [6] [10]. Those elements are the backbone of what a 510(k) summary for a typical vacuum erection device would report—intended use, technological characteristics, indications, and design controls such as pressure‑limiting valves [5] [6].
4. What is missing or uncertain in public reporting?
The reporting shows that many vendors assert “FDA‑cleared” status but does not provide their 510(k) summaries for independent review; apart from the Imagyn 510(k) PDF, the public summaries for Vacurect, Pos‑T‑Vac, Vitality, and other consumer brands were not included in the provided sources, so their specific predicates, performance testing, and risk mitigations cannot be independently verified here [2] [3] [4]. Industry commentary also notes that modern VEDs are often cleared by showing substantial equivalence to an original 510(k) from 1982, meaning some devices rely on long‑standing predicates rather than novel clinical data [11].
5. Marketing claims versus regulatory reality — read the fine print
Manufacturers and resellers have clear commercial incentives to call devices “FDA‑approved” or “medical grade,” language that can blur the distinction between clearance via 510(k) and full approval; consumers should note that FDA guidance actively defines required safety features (pressure limits, quick release) and labeling, and presence in GUDID or vendor claims does not substitute for reviewing a specific 510(k) summary when available [5] [2] [3]. Clinical sources warn that non‑cleared “penis developers” sold by mail order may reach dangerously high pressures and lack FDA clearance, a public‑health rationale for preferring documented 510(k) devices [10].