510(k) Report

FDA applicant

Radionics, Inc.

Burlington, MA56 decisions1982–20034 recalls

FDA records 56 decisions for Radionics, Inc. (Burlington, MA) from 1982 to 2003: 56 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and JXG (Shunt, Central Nervous System And Components). Its devices cite 29 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Radionics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Radionics, Inc. since 2007.

Recalls per year

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Radionics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radionics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument11decisions
  • JXGShunt, Central Nervous System And Components10decisions
  • IYEAccelerator, Linear, Medical7decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • GXDGenerator, Lesion, Radiofrequency4decisions
  • GXIProbe, Radiofrequency Lesion3decisions

Also: GYC (3), MUJ (3), IPF (1), GZL (1), JOT (1), GYK (1).

Whose devices does it build on?

Its devices cite 29 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 80 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K984552Cool-Tip RF SystemRadionics, Inc. · 199912cite it
  • K870028SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 19878cite it
  • K980430Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 19987cite it
  • K934523Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1)Radionics, Inc. · 19956cite it
  • K963577Radionics Sluijter-Mehta CannulaRadionics, Inc. · 19966cite it
  • K924226Ojemann Cortical StimulatorRadionics, Inc. · 19935cite it

What has FDA decided for it lately?

  • K030697Radionics Single Use Ground Pad (DGP-HP)Radionics, Inc. · 20031 recall
  • K001741Radionics RF Disc Catheter Electrode SystemRadionics, Inc. · 2000
  • K002773Neuromap with Neuro 100Radionics, Inc. · 2000
  • K992226XDS External CSF Drainage and Monitoring SystemRadionics, Inc. · 2000
  • K001950Optical Tracking System (Ots)Radionics, Inc. · 2000
  • K001700XPLAN 2.1Radionics, Inc. · 2000
  • K001431Modification to Optical Tracking System (Ots)Radionics, Inc. · 2000
  • K000057Radionics Lumboperitoneal ShuntRadionics, Inc. · 2000

All 56 as Radionics, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K924226Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for…Mar 18, 2013Class II
  • K030697DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits…Aug 1, 2012Class II
  • K984552Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation…Apr 21, 2006
  • K991237Radionics Head and Neck Localilizer (HNL), Version BMay 25, 2004

Other applicant names beginning “Radionics”

FDA records each applicant name separately; these may or may not be the same firm.

Radionics Software Applications, Inc. 12Radionics, A Division of Tyco Healthcare Group LP 8Radionics Medical, Inc. 5