510(k) Report

FDA applicant

Medtronic Navigation, Inc. (Littleton)

Littleton, MA1 decision2010–201018 recalls

FDA records 1 decision for Medtronic Navigation, Inc. (Littleton) (Littleton, MA) in 2010: 1 510(k) clearance. All are in product code OXO (Image-Intensified Fluoroscopic X-Ray System…). Its devices cite 2 predicates, 0 of them its own earlier devices. 18 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 Medtronic Navigation, Inc. (Littleton)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2019

2010: 22012: 12013: 22016: 12018: 112019: 1
2010high 11 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Navigation, Inc. (Littleton) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Navigation, Inc. (Littleton)’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?

  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 20102cite it

What has FDA decided for it lately?

  • K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 201018 recalls

The one decision as Medtronic Navigation, Inc. (Littleton) →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K092564Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where…May 1, 2019Class II
  • K092564O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number…Aug 30, 2018Class II
  • K092564O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number…Aug 30, 2018Class II
  • K092564O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB…Aug 30, 2018Class II
  • K092564O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number…Aug 30, 2018Class II
  • K092564O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number…Aug 30, 2018Class II