510(k) Report

FDA applicant

Rhytec Incorporated

Waltham, MA5 decisions2006–20081 recall

FDA records 5 decisions for Rhytec Incorporated (Waltham, MA) from 2006 to 2008: 5 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 12 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2008

2007: 22008: 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K071786Portrait PSRRhytec Incorporated · 20072cite it
  • K072394Portrait Stand-OffRhytec Incorporated · 20072cite it
  • K082197Rhytec, Inc., Portrait PSRRhytec Incorporated · 20081cites it
  • K060948Portrait PSR3Rhytec Incorporated · 20061cites it
  • K073111Portrait PSR, Model 745915Rhytec Incorporated · 20081cites it

What has FDA decided for it lately?

  • K082197Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
  • K073111Portrait PSR, Model 745915Rhytec Incorporated · 2008
  • K072394Portrait Stand-OffRhytec Incorporated · 2007
  • K071786Portrait PSRRhytec Incorporated · 2007
  • K060948Portrait PSR3Rhytec Incorporated · 20061 recall

All 5 as Rhytec Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060948Portrait PSR3 System, an electro-surgical device used in dermatological applicationsOct 2, 2006