Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PCT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
264 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023-02-10 | 151 | 0 |
| K180478 | RectalPro 75 Endorectal Balloon | Qlrad International , Ltd. | 2018-11-13 | 264 | 0 |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9 | Myriad Medical, LLC | 2015-03-31 | 57 | 0 |
| K141958 | ERB ENDORECTAL BALLOON | Edge Medical, LLC | 2014-11-18 | 123 | 0 |
| DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON | Radiadyne | 2014-01-28 | 197 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda