510(k) Report

FDA applicant

Biosys AB (Publ)

Chester, NY2 decisions1999–19990 recalls

FDA records 2 decisions for Biosys AB (Publ) (Chester, NY) in 1999: 2 510(k) clearances. All are in product code OLV (Standard Polysomnograph With…). Its devices cite 4 predicates, 1 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, neurology panel, where it files most

How often FDA has decided Biosys AB (Publ)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biosys AB (Publ) since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • OLVStandard Polysomnograph With Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 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.

  • K984580Biosaca SystemBiosys AB (Publ) · 19991cites it

What has FDA decided for it lately?

  • K991446Biosaca System, Model 800Biosys AB (Publ) · 1999
  • K984580Biosaca SystemBiosys AB (Publ) · 1999

All 2 as Biosys AB (Publ) →

Other applicant names beginning “Biosys”

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

Biosys Laboratories, Inc. 1Biosys Biyomedikal Muhendislik San. VE Tic. A.S. 1Biosys Co., Ltd. 1