510(k) Report

FDA applicant

Integra Radionics, Inc.

Burlington, MA10 decisions2006–20116 recalls

FDA records 10 decisions for Integra Radionics, Inc. (Burlington, MA) from 2006 to 2011: 10 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 20 predicates, 4 of them its own earlier devices. 6 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, radiology panel, where it files most

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

FDA decisions per year

1in 2011

2007: 22008: 12009: 22010: 22011: 1
2007high 2 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2014

2010: 22011: 12012: 22014: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Integra 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?

  • MUJSystem, Planning, Radiation Therapy Treatment4decisions
  • LFLInstrument, Ultrasonic Surgical4decisions
  • IYEAccelerator, Linear, Medical2decisions

Whose devices does it build on?

Its devices cite 20 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 20084cite it
  • K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 20073cite it
  • K102258Cusa NXT Extended Length TipIntegra Radionics, Inc. · 20111cites it

What has FDA decided for it lately?

  • K102258Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011
  • K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
  • K100417Xknife 5Integra Radionics, Inc. · 20101 recall
  • K090864Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemIntegra Radionics, Inc. · 2009
  • K083414Radionics Xknife HDRT SystemIntegra Radionics, Inc. · 2009
  • K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 20084 recalls
  • K072454Integra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. · 20071 recall
  • K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007

All 10 as Integra Radionics, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K081459Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory…Sep 29, 2014Class II
  • K100417Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software…Dec 10, 2012Class II
  • K072454Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and…Jan 23, 2012
  • K081459Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT…May 2, 2011
  • K081459Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx…Jul 29, 2010
  • K081459Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx…Jul 29, 2010

Other applicant names beginning “Integra”

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

Integra LifeSciences Corporation 101Integra Neurocare, LLC 12Integra Neurosciences 9Integra Lifesciences Production Corporation 9Integra Neurosciences Implants S.A. 6Integra Life Sciences 3Integra Medical 2Integra Lifescience Corportation 2Integra Lifesciences Corporation (Owner of Tei… 1Integra Microfrance 1Integra Biotechnical, LLC 1Integra Burlington Ma, Inc. 1