510(k) Report

FDA applicant

Sedat

San Diego, CA5 decisions2004–20085 recalls

FDA records 5 decisions for Sedat (San Diego, CA) from 2004 to 2008: 5 510(k) clearances. Most are in product codes DTL (Adaptor, Stopcock, Manifold, Fitting…) and MAV (Syringe, Balloon Inflation). Its devices cite 5 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Sedat S.A.”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2017

2012: 12014: 12017: 3
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sedat’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?

  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2decisions
  • MAVSyringe, Balloon Inflation2decisions
  • DQOCatheter, Intravascular, Diagnostic1decision

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K040498MyshellSedat S.A. · 20044cite it
  • K042449Dolphin Inflation DeviceSedat S.A. · 20052cite it
  • K082755Sedat FlamingoSedat · 20082cite it

What has FDA decided for it lately?

  • K082755Sedat FlamingoSedat · 20081 recall
  • K080472Sedat Myshell LiteSedat · 2008
  • K060010NautifluxSedat · 2006
  • K042449Dolphin Inflation DeviceSedat S.A. · 20054 recalls
  • K040498MyshellSedat S.A. · 2004

All 3 as Sedat →All 2 as Sedat S.A. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K042449DeRoyal (R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an…Jun 7, 2017Class II
  • K042449Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN…Apr 12, 2017Class II
  • K042449DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA-…Apr 5, 2017Class II
  • K042449Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use…Oct 6, 2014Class II
  • K082755Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular…May 10, 2012Class II