510(k) Report

FDA applicant

Osypka Medical, Inc.

La Jolla, CA7 decisions2002–20132 recalls

FDA records 7 decisions for Osypka Medical, Inc. (La Jolla, CA) from 2002 to 2013: 7 510(k) clearances. Most are in product codes DTE (Pulse-Generator, Pacemaker, External) and DSB (Plethysmograph, Impedance). Its devices cite 16 predicates, 5 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2013

2008: 32013: 1
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Osypka Medical, Inc.’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?

  • DTEPulse-Generator, Pacemaker, External4decisions
  • DSBPlethysmograph, Impedance3decisions

Whose devices does it build on?

Its devices cite 16 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 20082cite it
  • K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2Osypka Medical, Inc. · 20082cite it
  • K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber…Osypka Medical, Inc. · 20022cite it
  • K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and…Osypka Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K123916Psa SeriesOsypka Medical, Inc. · 2013
  • K082242Icon, Model C3Osypka Medical, Inc. · 2008
  • K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2Osypka Medical, Inc. · 2008
  • K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
  • K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003
  • K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and…Osypka Medical, Inc. · 2002
  • K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber…Osypka Medical, Inc. · 20022 recalls

All 7 as Osypka Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K020896Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085…Jun 30, 2010
  • K020896St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H /…Jun 30, 2010

Other applicant names beginning “Osypka”

FDA records each applicant name separately; these may or may not be the same firm.

Osypka AG 1