How to search the FDA 510(k) database for specific vacuum erection device model numbers
Executive summary
A targeted search for vacuum erection device (VED) model numbers starts with the FDA’s releasable 510(k) search (by Device Name, Product Code, 510(k) number or Panel) and can be tightened by pulling individual 510(k) summaries or the agency’s downloadable 510(k) files for text searches; the database and API also let experienced users build programmatic queries for large-scale or fuzzy matches [1] [2] [3]. Because manufacturers’ internal model-number conventions don’t always appear in the database summary fields, the most reliable method is to combine the FDA web search with direct inspection of the 510(k) PDFs and downloadable data, and—when necessary—use third‑party parsing or local text-search tools [1] [2] [4].
1. Start at the FDA releasable 510(k) search and pick the right field
The FDA’s releasable 510(k) search allows direct queries by Device Name, Product Code, 510(k) number or Panel; entering likely device names such as “vacuum erection device,” known product codes, or partial model names will return releasable records that list cleared device names and 510(k) numbers [1]. Guidance and how‑to writeups from consultants and compliance firms stress that a focused Device Name or Product Code search is the ordinary first step for locating candidate 510(k) records for a given device family [5] [6].
2. Inspect individual 510(k) records and downloadable PDFs for model numbers
Once candidate 510(k) records appear, open the specific 510(k) details and any linked summary or decision document—the model number (or manufacturer part numbers) is often included in the 510(k) summary or the PDF package attached to that record, as exemplified by manufacturer submissions such as the Imagyn “Irnpower System Vacuum Erection System” 510(k) document (K020969) which exists as a downloadable PDF in FDA archives [7] [8]. Practitioners caution that the searchable metadata fields on the portal may not contain every internal model identifier, so examining the full PDF is essential [7] [8].
3. Use downloadable 510(k) files for bulk or fuzzy model-number hunting
The FDA publishes downloadable zipped 510(k) datasets (monthly updates) that contain fixed‑length records suitable for programmatic parsing; these files are useful when model numbers aren’t captured cleanly in the web search or when running broad text matches across many records [2]. Legal and regulatory analysts who found the web interface limiting have exported or downloaded FDA files and built their own search engines or scripts—an approach recommended by commentators when precision searches for predicates or old model identifiers are required [4] [2].
4. Leverage the OpenFDA device 510(k) API and third‑party tools for automation
The OpenFDA 510(k) API provides a programmatic route to query 510(k) data, enabling automated searches for device names, manufacturers, or other fields and integration with local text-search routines to hunt model numbers appearing inside longer text blobs [3]. Regulatory consultants and blog guides advise combining the API with local parsing or a private index when the user needs repeated searches, fuzzy matching, or correlation with the GUDID (Global Unique Device Identification) data for more device-level detail [4] [9].
5. Expect limits, validate with the 510(k) PDF, and consult multiple sources
Searches can be frustrated by inconsistent naming: manufacturers use various strings for the same product, and older or withdrawn 510(k)s may be harder to find in simple keyword searches, so a search strategy should include multiple queries (device name variants, manufacturer names, product codes), PDF inspection, and—when necessary—downloading the full monthly files and parsing them for internal model numbers [1] [2] [4]. For step‑by‑step help, several industry guides and FDA pages walk through the portal and download options; those resources can speed the work but users should always verify claims by opening the original 510(k) PDFs [5] [6] [8].