What 510(k) records or FDA device listings exist for Encore Medical vacuum erection devices and what are their clearance dates?
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Executive summary
A targeted review of the provided reporting finds vendor product pages describing Encore-branded vacuum erection devices and general FDA 510(k) guidance pages, but the reporting does not include any specific FDA 510(k) record number or a documented FDA marketing-clearance date for an "Encore" vacuum erection device (VED) [1] [2] [3] [4] [5]. The evidence available shows commercial claims of FDA registration for Encore products on retailer pages, while the authoritative FDA 510(k) and PMN resources needed to confirm clearance numbers and dates are present in the reporting but contain no Encore-specific entries [1] [4] [5].
1. What the official FDA resources in the briefing actually are
The reporting includes the FDA’s public 510(k) and premarket notification pages — the CDRH listings that are published monthly and the PMN search tool — which are the authoritative places to find 510(k) numbers and clearance dates for devices (the FDA notes monthly listings of substantially equivalent 510(k)s and provides an accessdata PMN search for 510(k) submissions) [5] [4]. The reporting also includes explanatory material about the 510(k) process and the agency’s safety-and-effectiveness principles, establishing that a 510(k) is a premarket submission demonstrating substantial equivalence and that clearance is distinct from mere registration [6] [4].
2. What the vendor and distributor pages in the reporting claim
Multiple commercial listings and reseller pages in the reporting describe Encore Standard, Deluxe and battery-powered vacuum erection systems and in at least one case state the product is “FDA registered” or marketed OTC, but these pages do not provide a 510(k) number or FDA clearance date (examples include MedicalDepartmentStore, Allegro Medical, and OnlineMedicalSupply product pages) [1] [2] [3]. Those retailer claims are factual representations of the vendor listings in the reporting, but they are not the same as an FDA 510(k) clearance citation and do not substitute for an FDA record [1] [2].
3. What the reporting does not contain — no explicit Encore 510(k) record or clearance date
Nowhere in the supplied reporting is a specific FDA 510(k) entry, 510(k) number, or an FDA-stamped clearance date tied to “Encore” vacuum erection devices; the FDA PMN/510(k) pages included in the material are the correct lookup tools but were not shown returning an Encore-branded 510(k) in the provided snippets [4] [5]. Given the absence of a direct citation to a 510(k) number or a clearance date in the reporting, it is not possible from these sources alone to state a clearance date or 510(k) record for Encore VEDs.
4. Why vendor claims and FDA clearance are different things
Vendor statements that a product is “FDA registered” or “OTC” as shown on reseller pages reflect the retailer’s marketing language and/or device establishment registration status, which is administratively different from obtaining 510(k) marketing clearance; the FDA’s guidance explains that a 510(k) is a premarket submission demonstrating substantial equivalence and that 510(k) clearance is a distinct regulatory milestone [1] [4] [6]. Therefore, absence of a visible 510(k) citation on a product page is common and does not on its own prove clearance; conversely, a manufacturer or importer may hold a 510(k) under a different trade name or corporate submitter name — a search nuance covered by the FDA PMN tool [4] [5].
5. Practical next steps grounded in the reporting
To definitively answer whether Encore VEDs have a 510(k) clearance and to obtain clearance dates, the reporting points to the authoritative next step: search the FDA’s PMN/510(k) database and monthly CDRH 510(k) listings by product name, model, and manufacturer/sponsor — the FDA tools shown in the reporting are where 510(k) numbers and clearance dates are published [4] [5]. If an Encore device is not found there, alternative possibilities include that the device is marketed under another proprietary or company name, is registered but not 510(k)-cleared, or that the specific clearance record was not included in this set of sources; the provided reporting does not resolve those possibilities [1] [4].