510(k) Report

FDA applicant

Hydrocision, Inc.

Hopkonton, MA12 decisions1998–20252 recalls

FDA records 12 decisions for Hydrocision, Inc. (Hopkonton, MA) from 1998 to 2025: 12 510(k) clearances. Most are in product codes HRX (Arthroscope) and FQH (Lavage, Jet). Since 2016 its 510(k)s took a median of 68 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 9 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2025

2019: 12020: 12025: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hydrocision, 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?

  • HRXArthroscope9decisions
  • FQHLavage, Jet3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 68 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 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.

  • K982266Hydrocision Arthrojet SystemHydrocision, Inc. · 19984cite it
  • K041233Arthrojet XTHydrocision, Inc. · 20044cite it
  • K991383Hydrocision Debdridement SystemHydrocision, Inc. · 20002cite it
  • K020688Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 20022cite it
  • K002764Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 20002cite it
  • K011612Modification to Hydrocision Debridement SystemHydrocision, Inc. · 20012cite it

What has FDA decided for it lately?

  • K241990SpineSite Endoscope SystemHydrocision, Inc. · 2025
  • K200729HydroCision SpineJet SystemHydrocision, Inc. · 2020
  • K190804HydroCision TenJet DeviceHydrocision, Inc. · 2019
  • K041233Arthrojet XTHydrocision, Inc. · 2004
  • K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 20032 recalls
  • K021813Hydrocision General Surgery Fluidjet SystemHydrocision, Inc. · 2003
  • K020688Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
  • K011612Modification to Hydrocision Debridement SystemHydrocision, Inc. · 2001

All 12 as Hydrocision, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K032529Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of…Sep 7, 2006
  • K032529HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of…Sep 7, 2006