# K042607: Primus US

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Nov 26, 2004 after 63 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901713 (1990). 28 ancestors in all.
10 later devices descend from it; 4 cite it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System, Draeger Medical, Inc. (2004) Summary page 1.
- K983635: Julian Anesthesia Workstation, Model # Julian, Draeger Medical, Inc. (1999) Summary page 1.
- K033498: Narkomed 6400, Model NM6400, Draeger Medical, Inc. (2004) Summary page 1.
- K980208: Divan Anesthesia Ventilator, Draeger Medical, Inc. (1998) Summary page 1.
- K040847: Modification to Vamos Anesthetic Gas Monitor, Draeger Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own
- K133886: Perseus A500 (2014), 2 descendants of its own
- K230931: Atlan (2023), 1 descendant of its own

## Recalls of this device
- Jul 17, 2009 · Not classified · Z-1955-2009: Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
- Aug 22, 2008 · Not classified · Z-0087-2009: Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages fun

## Indications for use
The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and C02 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K042607
Methodology: https://510kreport.com/methodology