Home / 510(k) Clearances / K242818

510(k) K242818

IsoSphere by Isoaid, LLC — Product Code KXK

K242818 is an FDA 510(k) premarket notification submitted by Isoaid, LLC for the device "IsoSphere". The FDA issued a decision of Substantially Equivalent on July 15, 2025. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoaid, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2025
Date Received
September 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Isoaid, LLC

  • K141701 — I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] (December 5, 2014)
  • K113210 — ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT (August 10, 2012)
  • K091117 — ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA (September 15, 2009)
  • K033770 — ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (April 8, 2004)
  • K011205 — ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (July 10, 2001)

Other clearances for product code KXK

  • K252296 — OncoPatch (December 5, 2025)
  • K223465 — RadianceTx Radionuclide Brachytherapy Source (January 11, 2023)
  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)
  • K171487 — Sirius MRI Marker NS (August 25, 2017)

FDA data resources