Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isoaid, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
300 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242818 | IsoSphere | Isoaid, LLC | 2025-07-15 | 300 | 0 |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Isoaid, LLC | 2014-12-05 | 164 | 0 |
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | Isoaid, LLC | 2012-08-10 | 283 | 0 |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IA | Isoaid, LLC | 2009-09-15 | 151 | 0 |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | Isoaid, LLC | 2004-04-08 | 127 | 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