510(k) Report

FDA applicant

Khrunichev State Research & Production Space Centr

Deer Field, IL2 decisions2001–20060 recalls

FDA records 2 decisions for Khrunichev State Research & Production Space Centr (Deer Field, IL) from 2001 to 2006: 2 510(k) clearances. All are in product code CBF (Chamber, Hyperbaric). Its devices cite 1 predicate, 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, anesthesiology panel, where it files most

How often FDA has decided Khrunichev State Research & Production Space Centr’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Khrunichev State Research & Production Space Centr since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Khrunichev State Research & Production Space Centr 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?

  • CBFChamber, Hyperbaric2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K060739Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 20061cites it
  • K011312BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 20011cites it

What has FDA decided for it lately?

  • K060739Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
  • K011312BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001

All 2 as Khrunichev State Research & Production Space Centr →