510(k) Report

FDA applicant

Sainath Intellectual Properties, LLC

Tampa, FL3 decisions2009–20100 recalls

FDA records 3 decisions for Sainath Intellectual Properties, LLC (Tampa, FL) from 2009 to 2010: 3 510(k) clearances. All are in product code KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 8 predicates, 2 of them its own earlier devices. No 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sainath Intellectual Properties, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 12010: 2
2009high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sainath Intellectual Properties, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sainath Intellectual Properties, LLC’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?

  • KNTTubes, Gastrointestinal (And Accessories)3decisions

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.

  • K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 20092cite it

What has FDA decided for it lately?

  • K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010
  • K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC · 2010
  • K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009

All 3 as Sainath Intellectual Properties, LLC →