# K103035: Smartpilot View Model MK04500

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical GmbH
- Decided: Mar 28, 2012 after 532 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K000647 (2000). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071097: Navigator Applications Suite, GE Healthcare Finland Oy (2007) Summary page 3.
- K081941: Navigator Applications Suite, GE Healthcare Finland Oy (2008) Summary page 3.
- K083098: Navigator Applications Suite, GE Healthcare Finland Oy (2009) Summary page 3.
- K102389: Navigator Applications Suite, GE Healthcare Finland Oy (2011). Cleared while this submission was under review Summary page 3.
- K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer, Siemens Medical Solutions USA, Inc. (2002) Summary page 3.
- K030615: Infinity Explorer, Siemens Medical Solutions USA, Inc. (2003) Summary page 3.
- K040945: Modification to Infinity Explorer, Draeger Medical Systems, Inc. (2004) Summary page 3.
- K060254: Modification to Infinity Explorer, Draeger Medical Systems, Inc. (2006) Summary page 3.

## Cited in the summary but kept off the family tree
- K103515: Equal Dose, Nucletron Corporation (2011). Our reading of the summary gave K103515, FDA’s number for Equal Dose (Nucletron Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “Software Infinity Explorer”. Kept off the family tree. Summary page 3.

## Indications for use
The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PKIPD) and interactive P'D modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia. The SmartPilot View is intended for use with data, from adults only. The demographic ranges for these patient data are as follows: Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years

Source page: https://510kreport.com/device/K103035
Methodology: https://510kreport.com/methodology