FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO— 510(k) K081447

Clearance details

Applicant

Draeger Medical AG & Co. KG

Product code

Code BSZ

Device class

Class 2

Regulation

21 CFR 868.5160

Advisory panel

Anesthesiology

Date received

2008-05-22

Decision date

2008-10-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Luebeck, DE

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Death

23

Injury

298

Malfunction

32,987

Total

33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2253-2018 — Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and electronically controlled ventilator.Class II·Terminated·Draeger Medical, Inc.·20180524

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081447.