# K042974: Medicon Vipair High Speed System

- Pathway: 510(k) (Traditional)
- Applicant: Medicon EG
- Decided: Jan 13, 2005 after 77 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973736 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013091: ZMM 2000 Zeppelin Millennium Motordrill System, Von Zeppelin GmbH (2002) Summary page 2.
- K980686: Aesculap Hilan Motor System, Aesculap, Inc. (1998) Summary page 2.
- K991625: Komet XK-95 Perforator Motor (MI-102), Komet Medical (1999) Summary page 2.
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002) Summary page 2.
- K023066: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic), Sodemsystems (2002) Summary page 2.
- K965080: Anspach Micromax System, The Anspach Effort, Inc. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K092229: Thyretain TM Tsi Reporter Bioassay, Diagnostic Hybrids, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K950518: Miele G 7781 Dental Thermal Disinfector, Miele Professional (1996). Our reading of the summary gave K950518, FDA’s number for Miele G 7781 Dental Thermal Disinfector (Miele Professional). Its FDA name has none of the distinctive words the summary uses for the device it names, “Midas Rex, Midas Rex I, II”. Kept off the family tree. Summary page 2.
- K930660: Creatine Kinase (CK) Reagent Set, Pointe Scientific, Inc., (1993). Our reading of the summary gave K930660, FDA’s number for Creatine Kinase (CK) Reagent Set (Pointe Scientific, Inc.,). Its FDA name has none of the distinctive words the summary uses for the device it names, “Black Max by Anspach”. Kept off the family tree. Summary page 2.

## Indications for use
The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIPAIR" can be also used in the ENT and Orthopaedics. The Medicon VIPAIR high speed system are intended for use and handling by professional and qualified Neurology, ENT or Orthopaedic surgeons.

Source page: https://510kreport.com/device/K042974
Methodology: https://510kreport.com/methodology