510(k) Report

FDA applicant

Medrobotics Corporation

Raynham, MA5 decisions2015–20182 recalls

FDA records 5 decisions for Medrobotics Corporation (Raynham, MA) from 2015 to 2018: 5 510(k) clearances. Most are in product codes FDF (Colonoscope And Accessories, Flexible/Rigid) and EOB (Nasopharyngoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 36 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 of them its own earlier devices. 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2018

2015: 12017: 32018: 1
2015high 3 (2017) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2015high 2 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Medrobotics Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FDFColonoscope And Accessories, Flexible/Rigid2decisions
  • EOBNasopharyngoscope (Flexible Or Rigid)2decisions
  • HETLaparoscope, Gynecologic (And Accessories)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 246 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 36 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation · 20171cites it
  • K150776Medrobotics Flex SystemMedrobotics Corporation · 20151cites it

What has FDA decided for it lately?

  • K172796Flex Robotic System and Flex Transabdominal DriveMedrobotics Corporation · 2018
  • K170453Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017
  • K172036Medrobotics Flex Robotic SystemMedrobotics Corporation · 2017
  • K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation · 20172 recalls
  • K150776Medrobotics Flex SystemMedrobotics Corporation · 2015

All 5 as Medrobotics Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K162330Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of…Jan 25, 2019Class II
  • K162330Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of…Jan 25, 2019Class II