Isoaid, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Isoaid, LLC” (first 2001, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 158 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 283 |
| 2013 | 0 | — |
| 2014 | 1 | 164 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 300 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Isoaid, LLC took a median 300 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 6 | 6 |
Review panels
- Radiology (6)
Most recent Isoaid, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242818 | IsoSphere | KXK | 2025-07-15 | 300 |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | KXK | 2014-12-05 | 164 |
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | KXK | 2012-08-10 | 283 |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | KXK | 2009-09-15 | 151 |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | KXK | 2004-04-08 | 127 |
| K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 | KXK | 2001-07-10 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Isoaid, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Isoaid, LLC?
FDA lists 6 510(k) clearances under the applicant name “Isoaid, LLC” (first 2001, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Isoaid, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Isoaid, LLC is 158 days.
Which FDA product codes appear under Isoaid, LLC?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 6).
Next steps
- See all 6 Isoaid, LLC clearances with predicates and recalls
- Run predicate analysis for product code KXK, Isoaid, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.